2,2,2-trichloro-1-phenylethyl acetate

Acute Toxicity: dermal

Administrative data

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 study report

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

Acute Dermal Toxicity Study of test chemical in rats

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2,2-trichloro-1-phenylethyl acetate

EC Number:

201-972-0

EC Name:

2,2,2-trichloro-1-phenylethyl acetate

Cas Number:

90-17-5

Molecular formula:

C10H9Cl3O2

IUPAC Name:

2,2,2-trichloro-1-phenylethyl acetate

Test material form:

solid: particulate/powder

Details on test material:

2,2,2-trichloro-1-phenylethyl acetate/ 90-17-5/ 201-972-0
- IUPAC Name: 2,2,2-trichloro-1-phenylethyl acetate
- Purity: 99.91% (as per COA)
- Physical appearance: White crystaline powder
- pH: 5.40
- Density/Specific gravity: 0.982 g/cm3
- InChI: 1S/C10H9Cl3O2/c1-7(14)15-9(10(11,12)13)8-5-3-2-4-6-8/h2-6,9H,1H3
- Smiles: c1([C@@H](OC(C)=O)C(Cl)(Cl)Cl)ccccc1

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: In-House Bred at Sa-Ford, Animal Facility (CPCSEA Registration No. 1256/bc/09/CPCSEA)
- Females (if applicable) nulliparous and non-pregnant:yes
- Weight at study initiation:
Male:Minimum: 223 g and Maximum: 276 g
Female:Minimum: 212 g and Maximum: 232 g

- Fasting period before study:
- Housing:All cages were provided with corn cobs (Sparconn Life Sciences Bangalore) Batch No.: SPAR – 24/2013
- Diet (e.g. ad libitum): All animals were provided conventional laboratory rodent diet (Nutrivet Life Sciences, Pune) ad libitum. Batch No 400012
- 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 6 days prior to administration of the test item.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Minimum: 20.50 °C Maximum: 24.40 °C
- Humidity (%): Minimum: 36.60% Maximum: 57.30%
- Air changes (per hr): More than 12 changes per hour
- Photoperiod (hrs dark / hrs light): 12:12

IN-LIFE DATES: From: To:30-01-2014 to 22-02-2014

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: fur of dorsal area of the trunk
- % coverage: 10%
- Type of wrap if used: porous gauze dressing and non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: 24 hrs

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: yes
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.2 ml

Duration of exposure:

24 hrs

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

10 (5/sex)

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed at 1, 2, 3 and 4 hours post dosing on day 0 (day of dosing)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Yes

Statistics:

Not specified

Results and discussion

Preliminary study:

Not specified

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other:

Remarks:

No mortality observed

Mortality:

No mortality was observed at limit dose of 2000 mg/kg body weight of test item during the 14 day observation period (refer table 3).

Clinical signs:

other: No systemic or local signs of toxicity were observed at limit dose of 2000 mg/kg body weight of test item during the experimental period (refer table 2).

Gross pathology:

The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality (refer table 5).

Other findings:

No data

Any other information on results incl. tables

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

 

Dose:2000 mg/ kg bodyweight                                                                                                         

Animal No.	Sex	Body Weight (gram)			Body Weight Change (%)
		Day 0	Day 7	Day 14	Day 0-7	Day 0-14
1	Male	223	245	256	9.87	14.80
2		276	291	312	5.43	13.04
3		238	253	257	6.30	7.98
4		242	254	261	4.96	7.85
5		242	250	283	3.31	16.94
6	Female	223	230	246	3.14	10.31
7		232	244	242	5.17	4.31
8		212	213	215	0.47	1.42
9		213	224	224	5.16	5.16
10		219	225	231	2.74	5.48

Key:* = Based on day 0 body weight taken prior to dose application.

Table 2: Individual Animal Clinical Signs and Symptoms

 

Dose:2000 mg/kg body weight

Animal No.	Sex	Hour(s) - Day 0				Day
		1	2	3	4	1	2	3	4	5	6	7	8	9	10	11	12	13	14
1	Male	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1
2		1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1
3		1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1
4		1	1	1	1	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	1	1	1	1
6	Female	1	1	1	1	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	1	1	1	1
8		1	1	1	1	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	1	1	1	1
10		1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1

Key: 1 = Normal

Table 3: Individual Animal Mortality Record

 

Dose:2000 mg/kg body weight

Animal No.	Sex	Days of Observation (0 to 14)
		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

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

Result obtained from present investigation can be concluded that the test chemical is acutely non toxic at the tested dose level of 2000 mg/kg b.wt in wistar rats when applied by dermal route. The acute dermal LD50 of test chemical found to be more than 2000 mg/kg b.wt. (> 2000 mg/kg b.wt.).

Executive summary:

Acute dermal toxicity study of test chemical was conducted 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 moistened with 0.2 ml distilled water was applied by single dermal application and observed for 14 days after treatment. On test day 0, an amount of test item moistened with 0.2 ml distilled water was applied directly on the intact skin of clipped area of rats; the surgical gauze patch was put on to the intact skin of clipped area. This gauze patch was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with non-irritating adhesive 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). Bodyweights 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. No clinical signs and any skin reaction were observed throughout the experimental period in all treated animals. The male and female animals were observed with body weight gain compared to day 0 throughout the experiment. The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality. Therefore, under the conditions of this; the acute dermal median lethal dose of test chemical was > 2000 mg/kg body weight. It can be concluded that test compound is acutely non toxic to wistar rats.