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REACH

Dodecan-1-ol, ethoxylated

EC number: 500-002-6 | CAS number: 9002-92-0 1 - 2.5 moles ethoxylated

Life Cycle description
Uses advised against

Toxicological information

Endpoint summary

Administrative data

Description of key information

Acute oral toxicity:

The acute oral toxicity dose (LD50) was considered based on different experimental studies conducted on rats and mice for the test chemical. The LD50 value is 1000 mg/kg bw. The study concluded that the LD50 value is between 300-2000 mg/kg bw, for acute oral toxicity. Thus, comparing this range with the criteria of CLP regulation, the given test chemical can be classified into the “Category 4” for acute oral toxicity.

Acute Inhalation Toxicity:

The acute toxicity inhalation study need not be conducted because exposure to humans via inhalation route is not likely taking into account the low vapour pressure of the substance, which is reported as 1.77E-5 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the test chemical is highly unlikely. Therefore this study is considered for waiver.

Acute Dermal toxicity:

The acute dermal toxicity dose (LD50) was considered based on experimental studies conducted on rats for the test chemical. The LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Data is from experimental study report.

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Principles of method if other than guideline:

The aim of this study was to assess the toxicity potential of the given test chemical after single oral administration in rats and 14 day observation period.

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: In-House Bred
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8- 10 weeks at the time of dosing. Healthy young adult animals were used for the study.
- Weight at study initiation: Minimum: 135 g Maximum: 159 g (Individual body weights were within ± 6% prior to treatment after overnight fasting)
- Fasting period before study: rat were fasted for 16 to 18 hours, prior to dosing
- Housing: The animals were housed individually in polycarbonate cages.
- Bedding:All cages were provided with corn cobs
- Room Sanitation:The experimental room floor and work tops were swept and mopped with disinfectant solution every day.
- Cages and water bottle:All the cages and water bottles were changed at least twice every week.
- Diet (e.g. ad libitum): All animals were provided conventional laboratory rodent diet (Nutrivet Life Sciences, Pune) ad libitum.
- Water (e.g. ad libitum): Aqua guard filtered tap water was provided ad libitum via drinking bottles.
- Acclimation period: Animal nos. 1-3 were acclimatized for 5 days, 4-6 for 8 days and 7-9 for 12 days, prior to administration of the test item.
- Identification:The animals were marked temporarily on tail, permanently on toe pad micro tattooing and cage cards. Individual cage cards were labelled with study no., study type, test system, group, dose, sex, animal number, experimental start and completion date.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Minimum: 19.60°C; Maximum: 23.30°C
- Humidity (%): Minimum: 51.80 % ; Maximum: 64.30 %
- Air changes (per hr): More than 12 changes per hour
- Photoperiod (hrs dark / hrs light): 12:12

IN-LIFE DATES: From: April 25, 2014 To:June 26, 2014

Route of administration:

oral: unspecified

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2000 mg/kg and 300 mg/kg
- Amount of vehicle (if gavage): 10 ml/kg body weight

Doses:

2000 and 300 mg/kg dose level

No. of animals per sex per dose:

2000 mg/kg bw-3 female rats
300 mg/kg bw-6 female rats

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical Observation - After test item administration, individual animals were frequently observed at 30 minutes, 1, 2, 3 and 4 hours post dosing on day 0 (day of dosing). Additionally, animal nos. 1-3 were observed at 6 hours post dosing. Subsequently, all surviving animals were observed once a day during the 14 day observation period.
- Mortality - All surviving animals were observed twice daily (morning and evening) for morbidity and mortality, throughout the acclimatization and study period.
- Body weight - All surviving rats were weighed on days 0 (prior to dosing), 7 and 14. Animals were weighed immediately after found dead.
- Necropsy of survivors performed: yes, at the end of 14 day observation period, all surviving rats were euthanised by overdose of CO2 for external and internal observations.

Statistics:

not specified

Preliminary study:

not specified

Sex:

female

Dose descriptor:

LD50

Effect level:

1 000 mg/kg bw

Based on:

test mat.

Mortality:

At 2000 mg/kg, animal nos. 2 and 3 were found dead on day 1 post dosing, whereas all other animals treated with 2000 and 300 mg/kg dose level were survived througout the experimentation period.

Clinical signs:

other: At 2000mg/kg, animal no. 1 was observed with mild diarrhea at 30 minutes and 1 hour post dosing, mild lethargy at 1, 2, 3 and 4 hours, soiled anal region with feces and urine at 1, 2 and 3 hours, epistaxis at 3 hours, soiled anal region with urine at 4, 6

Gross pathology:

At 2000 mg/kg, found dead animal nos. 2 and 3 were observd with wet area around anal region during external gross pathological examination and moderate to severe red discolouration of all lobes of the lungs during internal gross pathological examination. Whereas, no external and internal gross pathological changes were seen in the other animals treated with 2000 and 300 mg/kg body weight during terminal sacrifice.

Other findings:

not specified

Table 1: Individual Animal Body Weight (g) andBody Weight Changes(%)

Sex:Female

Animal No.	Group/ Dose (mg/kg)	Body Weight (gram)				Body Weight Change (%)
Animal No.	Group/ Dose (mg/kg)	Day 0	Day 7	Day 14	Found Dead	Day 0-7	Day 0-14
1	2000	136	146	175	-	7.35	28.68
2		138	-	-	129	-	-
3		135	-	-	130	-	-
4	300	143	181	190	-	26.57	32.87
5		148	176	193	-	18.92	30.41
6		145	180	200	-	24.14	37.93
7		154	186	196	-	20.78	27.27
8		159	196	206	-	23.27	29.56
9		158	185	197	-	17.09	24.68

Key:- = not applicable.

Table 2: Summary of Animal Body Weight (g) and Body Weight Chang

Sex:Female

Group/ Dose (mg/kg)		Rats Body Weight (g)			Body Weight Changes (%)
Group/ Dose (mg/kg)		Day 0	Day 7	Day 14	0-7	0-14
G1/ 2000	Mean	136.33	-	-	-	-
	SD	1.53	-	-	-	-
	n	3	-	-	-	-
G2/ 300	Mean	151.17	184.00	197.00	21.79	30.45
	SD	6.79	6.90	5.59	3.52	4.60
	n	6	6	6	6	6

Keys:- = not applicable, SD = Standard Deviation, n = Number of Animals.

Table 3: Individual Animal Clinical Signs and Symptoms

Sex:Female

Animal No.	Group/ Dose (mg/kg)	Hours (Day 0)
Animal No.	Group/ Dose (mg/kg)	1/2	1	2	3	4	6
1	G1/ 2000	49⁺	49⁺ 99⁺ 184*	99⁺ 184*	99⁺ 64 184*	99⁺ 184**	184**
2		1	49⁺ 99⁺ 184*	99⁺ 184*	99⁺⁺ 21⁺ 184**	99⁺⁺ 21⁺ 184**	99⁺⁺ 184** 21⁺
3		49⁺	49+ 99⁺ 184*	99⁺ 184*	99⁺⁺ 21⁺ 184**	99⁺⁺ 21⁺ 184**	98 184**
4	G2/ 300	99⁺	99⁺	99⁺	1	1	-
5		49⁺ 99⁺	49⁺ 99⁺	99⁺	1	1	-
6		49⁺ 99⁺	49⁺ 99⁺	99⁺	1	1	-
7		99⁺	99⁺	99⁺	1	1	-
8		49⁺ 99⁺	49⁺ 99⁺	99⁺	1	1	-
9		99⁺	99⁺	99⁺	1	1	-

Keys:- = Not applicable, 1 = Normal, 21 = Ataxia, 49 = Diarrhoea, 64 = Epistaxis, 98 = Lateral recumbancy, 99 = Lethargy, 184* = Soiled anal region with feaces and urine, 184** = Soiled anal reagion with urine,⁺= mild,⁺⁺= moderate.

Table 3 (Continued): Individual Animal Clinical Signs and SymptomsSex:Female

Animal No.	Group/ Dose (mg/kg)	Days post dosing
Animal No.	Group/ Dose (mg/kg)	1	2	3	4	5	6	7	8	9	10	11	12	13	14
1	G1/ 2000	184**	1	1	1	1	1	1	1	1	1	1	1	1	1
2		155 4⁺ 184** 2	-	-	-	-	-	-	-	-	-	-	-	-	-
3		98 184** 4⁺ 2	-	-	-	-	-	-	-	-	-	-	-	-	-
4	G2 / 300	1	1	1	1	1	1	1	1	1	1	1	1	1	1
5		1	1	1	1	1	1	1	1	1	1	1	1	1	1
6		1	1	1	1	1	1	1	1	1	1	1	1	1	1
7		1	1	1	1	1	1	1	1	1	1	1	1	1	1
8		1	1	1	1	1	1	1	1	1	1	1	1	1	1
9		1	1	1	1	1	1	1	1	1	1	1	1	1	1

Keys: - = Not applicable, 1 = Normal, 2 =found dead , 4 = abdominal breathing, 98 = Lateral recumbancy, 155 = Sternal recumbency, 184** = Soiled anal reagion with urine,⁺= mild.

Table 4: Individual Animal Mortality Record

Sex:Female

Animal No.	Group/ Dose (mg/kg)	Day of Observation (Day 0 to 14)
Animal No.	Group/ Dose (mg/kg)	Morning Observations	Evening Observations
1	G1/ 2000	No mortality and morbidity	No mortality and morbidity
2		No mortality and morbidity till day 1 Found dead on day 1	No mortality and morbidity on day 0
3		No mortality and morbidity till day 1 Found dead on day 1	No mortality and morbidity on day 0
4	G1/ 300	No mortality and morbidity	No mortality and morbidity
5		No mortality and morbidity	No mortality and morbidity
6		No mortality and morbidity	No mortality and morbidity
7		No mortality and morbidity	No mortality and morbidity
8		No mortality and morbidity	No mortality and morbidity
9		No mortality and morbidity	No mortality and morbidity

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Under the conditions of this, acute oral toxicity dose (LD50) was considered to be 1000 mg/kg body weight, when female Wistar rats were treated with the given test chemical via oral route.
CLP classification: “Category 4” LD50 > 300-2000 mg/kg body weight.

Executive summary:

Acute oral toxicity study of the given test chemical was conducted as per OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method) in female Wistar Rats. Nine female Wistar rats were selected for acute oral toxicity study. The animals were fasted for minimum 16-18 hours prior to dosing and for 4 hours post dosing, with food withheld but drinking water provided ad libitum. The time intervals between dosing were determined by the onset, duration and severity of toxic signs.

Three rats of group G1 were dosed with starting dose of 2000 mg/kg body weight and two animals died on day 1 post dosing, so three rats of group G2 were dosed with 300 mg/kg weight and no mortality was observed. Further, three animals of the same group G2 were dosed with 300 mg/kg weight and no mortality was observed. Hence, further dosing was stopped.

Body weights were recorded on day 0 (prior to dosing) 7 and 14. Animals were weighed immediately after found dead. Mean body weight of animals treated with 300 mg/kg body weight was observed with gain on day 7 and 14, as compared to day 0.

At 2000mg/kg, animal no. 1 was observed with mild diarrhoea at 30 minutes and 1 hour post dosing, mild lethargy at 1, 2, 3 and 4 hours, soiled anal region with faeces and urine at 1, 2 and 3 hours, epitasis at 3 hours, soiled anal region with urine at 4, 6 hours and on day 1, followed by normal clinical sign till day 14. Animal no. 2 was observed with normal sign at 30 minutes, mild diarrhoea at 1 hour, mild to moderate lethargy at 1, 2, 3, 4 and 6 hours, soiled anal region with faeces and urine at 1, 2 and 3 hours, mild ataxia at 3, 4 and 6 hours, soiled anal region with urine at 3, 4, 6 hours and on day 1, sternal recumbency, mild abdominal breathing and found dead on day 1. Animal no. 3 was observed with mild diarrhoea at 30 minutes and 1 hour, mild to moderate lethargy at 1, 2, 3 and 4 hours, soiled anal region with faeces and urine at 1 and 2 hours, mild ataxia at 3 and 4 hours, soiled anal region with urine at 3, 4, 6 hours and on day 1, lateral recumbency at 6 hours and on day 1, mild abdominal breathing and found dead on day 1. At 300 mg/kg, animal no. 4, 7 and 9 were observed with mild lethargy at 30 minutes, 1 and 2 hours post dosing, followed by normal clinical sign till day 14. Animal no. 5, 6 and 8 were observed with mild lethargy at 30 minutes, 1 and 2 hours, mild diarrhoea at 30 minutes and 1 hour and normal clinical sign till day 14.

At 2000 mg/kg, found dead animal nos. 2 and 3 were observed with wet area around anal region during external gross pathological examination and moderate to severe red discolouration of all lobes of the lungs during internal gross pathological examination. Whereas, no external and internal gross pathological changes were seen in the other animals treated with 2000 and 300 mg/kg body weight during terminal sacrifice.

Under the conditions of this, acute oral toxicity dose (LD50) was considered to be 1000 mg/kg body weight, when female Wistar rats were treated with the given test chemical via oral route. CLP classification: “Category 4” LD50 > 300-2000 mg/kg body weight.

Endpoint conclusion

Endpoint conclusion:: adverse effect observed
Dose descriptor:: LD50
Value:: 1 000 mg/kg bw
Quality of whole database:: Data is Klimisch 1 and from study report.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:: acute toxicity: inhalation
Data waiving:: other justification
Justification for data waiving:: other:
Clinical signs:: other:

Endpoint conclusion

Quality of whole database:: Waiver

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Data is from experimental study report.

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

The objective of the study was to assess the dermal toxicity of the given test chemical after single dose application by dermal route in rats and an observation period of 14 days.

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: In-House Bred
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Healthy young adult animals were used for the study
- Weight at study initiation: Male:Minimum: 249 g and Maximum: 283 g
(Prior to Treatment)Female:Minimum: 234 g and Maximum: 246 g
- Housing:The animals were housed individually in polycarbonate cages.
- Bedding:All cages were provided with corn cobs
- Room Sanitation:The experimental room floor and work tops were swept and mopped with disinfectant solution every day.
- Cages and water bottle:All the cages and water bottles were changed at least twice every week.
- Diet (e.g. ad libitum): All animals were provided conventional laboratory rodent diet, ad libitum.
- Water (e.g. ad libitum):Aqua guard filtered tap water was provided ad libitum via drinking bottles.
- Acclimation period:All animals were acclimatized to the test conditions for 7 days prior to administration of the test item.
- Identification:During Acclimatization, animals were temporarily marked by permanent marker, on their tails. After acclimatization, the animals were marked by toe pad micro tattooing and cage cards. Individual cage cards were labelled with study no., study type, test system, sex, animal number, experimental start and completion date.
- Randomization:Animals were selected manually. No computer generated randomization program was used.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Minimum: 19.70 °C; Maximum: 23.30 °C
- Humidity (%): Minimum: Minimum: 51.80% ; Maximum: 64.30%
- Air changes (per hr): More than 12 changes per hour
- Photoperiod (hrs dark / hrs light): 12:12

IN-LIFE DATES: From:April 25, 2014 To: May 23, 2014

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: The test item was applied uniformly over clipped dorsal area of rat skin.
- % coverage: approximately 10%
- Type of wrap if used: Test item was held in contact with the skin with a porous gauze dressing and non-irritating tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, residual test item was removed by using distilled water.
- Time after start of exposure: 24-hour.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

10 (Five per sex)

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical Observation - After test item administration, individual animals were frequently observed at 1, 2, 3 and 4 hours post dosing on day 0 (day of dosing). Subsequently, all animals were observed once a day during the 14 day observation period.
Mortality - Animals were observed twice daily for any mortality during the experimental period.
Body weight - All rats were weighed on days 0 (prior to dosing), 7 and 14.
Local Signs/Skin Reactions - All animals were observed once daily during days 1-14 (in common with clinical signs).
- Necropsy of survivors performed: yes, at the end of 14 day observation period, all the surviving rats were euthanised by overdose of CO2 and subjected to gross pathology examination, for external and internal observations.

Statistics:

No statistical analysis was performed since the study was terminated with limit test.

Preliminary study:

Limit Test - Five male and five female wistar rats were treated with test item by a single dermal application at the dose level of 2000 mg/kg body weight. Since no test item related mortality was observed, the study was terminated with limit test only.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed at limit dose of 2000 mg/kg body weight of test item during the 14 day observation period.

Clinical signs:

other: All the animals were observed with normal clinical signs throughout the experimental period.

Gross pathology:

The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality.

Other findings:

not specified

Table 1: Individual Animal Body Weight (g) andBody Weight Change%

Dose:2000 mg/ kg bodyweight Density:0.9137

Animal No.	Sex	Dose Volume* (ml)	Body Weight (gram)			Body Weight Change (%)
Animal No.	Sex	Dose Volume* (ml)	Day 0	Day 7	Day 14	Day 0-7	Day 0-14
1	Male	0.60	273	295	308	8.06	12.82
2		0.56	258	279	304	8.14	17.83
3		0.62	283	305	312	7.77	10.25
4		0.55	249	264	272	6.02	9.24
5		0.56	256	268	276	4.69	7.81
6	Female	0.51	234	232	230	-0.85	-1.71
7		0.51	234	238	242	1.71	3.42
8		0.51	234	232	236	-0.85	0.85
9		0.54	246	243	244	-1.22	-0.81
10		0.52	236	236	239	0.00	1.27

Key:* = based on density and day 0 body weight

Table 2: Individual Animal Clinical Signs and Symptoms

Animal No.	Sex	Hour(s) - Day 0				Day
Animal No.	Sex	1	2	3	4	1	2	3	4	5	6	7
1	Male	1	1	1	1	1	1	1	1	1	1	1
2		1	1	1	1	1	1	1	1	1	1	1
3		1	1	1	1	1	1	1	1	1	1	1
4		1	1	1	1	1	1	1	1	1	1	1
5		1	1	1	1	1	1	1	1	1	1	1
6	Female	1	1	1	1	1	1	1	1	1	1	1
7		1	1	1	1	1	1	1	1	1	1	1
8		1	1	1	1	1	1	1	1	1	1	1
9		1	1	1	1	1	1	1	1	1	1	1
10		1	1	1	1	1	1	1	1	1	1	1

Animal No.	Sex	Day
Animal No.	Sex	8	9	10	11	12	13	14
1	Male	1	1	1	1	1	1	1
2		1	1	1	1	1	1	1
3		1	1	1	1	1	1	1
4		1	1	1	1	1	1	1
5		1	1	1	1	1	1	1
6	Female	1	1	1	1	1	1	1
7		1	1	1	1	1	1	1
8		1	1	1	1	1	1	1
9		1	1	1	1	1	1	1
10		1	1	1	1	1	1	1

Keys: 1 = Norma

Table 3: Individual Animal Mortality Record

Dose:2000 mg/kg body weight

Animal No.	Sex	Days of Observation (0 to 14)
Animal No.	Sex	Morning Observations	Evening Observations
1	Male	No mortality and morbidity	No mortality and morbidity
2		No mortality and morbidity	No mortality and morbidity
3		No mortality and morbidity	No mortality and morbidity
4		No mortality and morbidity	No mortality and morbidity
5		No mortality and morbidity	No mortality and morbidity
6	Female	No mortality and morbidity	No mortality and morbidity
7		No mortality and morbidity	No mortality and morbidity
8		No mortality and morbidity	No mortality and morbidity
9		No mortality and morbidity	No mortality and morbidity
10		No mortality and morbidity	No mortality and morbidity

Table 4:Summaryof Animal Body Weight (g) and Body Weight Changes (%)

Dose:2000 mg/kg body weight

Sex		Body Weight (gram)			Body Weight Changes (%)
Sex		Day 0	Day 7	Day 14	Day 0-7	Day 0-14
Male	Mean	263.80	282.20	294.40	6.94	11.59
	SD	13.85	17.51	18.89	1.52	3.94
	n	5	5	5	5	5
Female	Mean	236.80	236.20	238.20	-0.24	0.60
	SD	5.22	4.60	5.50	1.18	1.99
	n	5	5	5	5	5

Keys:SD= Standard deviation, n = Number of animals

Interpretation of results:

other: Not classified

Conclusions:

Under the conditions of this, acute dermal toxicity dose (LD50) value for given test chemical was considered to be >2000 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that the given test chemical does not exhibit acute dermal toxicity i.e it is acutely non toxic to animals.

Executive summary:

Acute dermal toxicity study was conducted for the given test chemical as per OECD No.402 in Wistar Rats.

Five male and five female healthy young adult rats were randomly selected and used for conducting acute dermal toxicity study. Rats free from injury and irritation of skin were selected for the study. Twenty four hours prior to dermal application of test item, approximately 10% of body surface area of each rat was clipped. A limit dose of 2000 mg/ kg body weight of test item based on the density (0.9137) and latest body weight was applied by single dermal application and observed for 14 days after treatment.

On test day 0, calculated amount of test item was applied directly on the intact skin of clipped area of rats; the porous gauze dressing was put on to the intact skin of clipped area. This porous gauze dressing was covered with a non-irritating tape. After the 24-hour application period, the dressings were removed and the skin was gently wiped with distilled water. The skin reactions were assessed.

The animals were observed daily for mortality and clinical signs, during the acclimatization period. All animals were observed for clinical signs at approximately 1, 2, 3 and 4 hours after treatment on day 0 and once daily during test days 1‑14. Mortality was recorded after application on test day 0 and twice daily during days 1-14 (at least once on the day of sacrifice). Local signs / Skin reactions were observed daily from test days 1-14 (in common with clinical signs). Body weights were recorded on day 0 (prior to application) and on day 7 and 14. All animals were necropsied and examined macroscopically.

No mortality was observed in any animal till the end of the experimental period. All the animals were observed with normal clinical signs throughout the experimental period. In males, mean body weight was observed with increase on day 7 and 14, as compared to day 0. In females, mean body weight was observed with decrease on day 7 and increase on 14, as compared to day 0. The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality.

Endpoint conclusion

Endpoint conclusion:: no adverse effect observed
Dose descriptor:: LD50
Value:: 2 000 mg/kg bw
Quality of whole database:: Data is Klimisch 1 and from study report.

Additional information

Acute oral toxicity:

In different studies, the given test chemical has been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats and mice for test chemical. The studies are summarized as below –

Under the conditions of this, acute oral toxicity dose (LD50) was considered to be 1000 mg/kg body weight, when female Wistar rats were treated with the given test chemical via oral route. CLP classification: “Category 4” LD50 > 300-2000 mg/kg body weight.

The above study is supported with another study mentioned in peer-reviewed journal for the test chemical and was conducted in rats at the dose concentration range of 1190 mg/kg bw. Animals were observed for mortality over 5 days. 50% mortality was observed at 1190 mg/kg bw in treated animals. Hence, the LD50 value was considered to be 1190 mg/kg bw, when rats were treated with the given test chemical via oral route.

These studies are supported with the study mentioned in handbook and authoritative database for the test chemical and conducted in rats at the dose concentration of 1000 mg/kg bw. Animals were observed for mortality. 50% mortality was observed at 1000 mg/kg bw in treated animals. Hence, the LD50 value was considered to be 1000 mg/kg bw, when rats was treated with the given test chemical via oral route.

All the above studies are further supported with the study mentioned in different handbooks and database for the test chemical and conducted in mice at the dose concentration of 1170 mg/kg bw. Animals were observed for mortality. 50% mortality was observed at 1170 mg/kg bw in treated animals. Hence, the LD50 value was considered to be 1170 mg/kg bw, when mice was treated with the given test chemical via oral route.

Thus, from the above summarized studies conducted on rats and mice, the LD50 value was considered in between 300-2000 mg/kg bw, for acute oral toxicity. Therefore, comparing this range with the criteria of CLP regulation, the given test chemical can be classified into the “Category 4” for acute oral toxicity.

Acute Inhalation Toxicity:

Acute Dermal Toxicity:

Acute dermal toxicity study was conducted for the given test chemical as per OECD No.402 in Wistar Rats.

The animals were observed daily for mortality and clinical signs, during the acclimatization period. All animals were observed for clinical signs at approximately 1, 2, 3 and 4 hours after treatment on day 0 and once daily during test days 1‑14. Mortality was recorded after application on test day 0 and twice daily during days 1-14 (at least once on the day ofsacrifice). Local signs / Skin reactions were observed daily from test days 1-14 (in common with clinical signs). Body weights were recorded on day 0 (prior to application) and on day 7 and 14. All animals were necropsied and examined macroscopically.

The above study is supported with another study conducted on rats and mentioned in study report for the test chemical.

The acute dermal toxicity study of the given test chemical was conducted on Wistar albino rats. This study was conducted according to OECD guideline 402 for testing of chemicals. The summary of the study was as follows -

LIMIT TEST (2000 mg/kg body weight): Ten healthy wistar albino rats of both sex (ranging b.wt 200±30 gm) was selected for study after acclimatization. Approximate 10 % back skin of total body surface area was prepared 24 hrs prior to application of test compound. The test compound was applied dermally at the dose level of 2000 mg/kg b.wt for each animal. The treated animals were closely observed for clinical signs of intoxication during first four hours of test compound administration. Thereafter, all the animals were observed periodically at one hour interval for 24 hrs and twice daily for a period of 14 days. The body weight of each rat was observed on day 0 (pre treatment), 7th and 14th (post treatment). The necropsy was performed on all animals at the termination of the study.

The test compound applied dermally at the dose level of 2000 mg/kg b.wt in Wistar albino rats did not show any mortality as well as clinical signs of toxicity throughout the observation period of 14 days. Necropsy finding did not reveal any gross pathological changes under test condition.

After 72 hrs, a confirmatory test was conducted in same species of animals to confirm the results obtained from limit test (OECD-402 guidelines). Ten healthy Wistar albino rats of both sex (ranging b.wt 200±30 gm) was selected for study after acclimatization. Approximate 10 percent back skin of total body surface area was prepared 24 hrs prior to application of test compound. The test drug was applied dermally at the dose level of 2000 mg/kg b.wt for each animal. The treated animals were closely observed for clinical signs of intoxication during first four hours of test compound administration. Thereafter, all the animals were observed periodically at one hour interval for 24 hrs and twice daily for a period of 14 days. The body weight of each rat was observed on day 0 (pre treatment), 7th and 14th (post treatment). The necropsy was performed on all animals which at the termination of the study.

No mortality was recorded in Wistar albino rats after administration of test compound at the dose level of 2000 mg/kg b.wt throughout the period of observation (14 days). The test compound did not elicit any clinical signs of toxicity during the observation period. No skin reaction was observed after 24th hrs of patch removal. The body weight of each animal recorded on day 7th and 14th showed normal increase as compared to day 0 (pre treatment).

From the results obtained from present investigation, it can be concluded that the test chemical is non toxic to Wistar albino rats at the dose level of 2000 mg/kg body weight and the LD50 of this compound is >2000 mg/kg body weight.

Thus, from the above summarized studies conducted on rats, the LD50 value was considered to be >2000 mg/kg bw, for acute dermal toxicity. Therefore, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.

Justification for classification or non-classification

Based on the above studies on test chemical, it can be concluded that the LD50 value is between 300 - 2000 mg/kg bw, for acute oral toxicity and LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this range and value with the criteria of CLP regulation, the given test chemical can be classified into the “Category 4” for acute oral toxicity and cannot be classified for acute dermal toxicity. For acute inhalation toxicity wavier was added so, not possible to classify.

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