1,2,3-Propanetriol, homopolymer, docosanoate

Endpoint summary

Description of key information

In an acute oral toxicity study the LD50 value was determined to be > 2000 mg/kg bw. In an acute dermal toxicity study the LD50 value was > 2000 mg/kg bw.

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:

other: GLP guideline study

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, FRG
- Age at study initiation: young adult animals
- Weight at study initiation: animals of comarable weight (150 - 300 g; ± 20% of the mean weight)
- Fasting period before study: at least 16 hours before administration
- Housing: single housing in stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, FRG)
- Diet: Kliba-Labordiaet 343 (Klingentalmuehle AG, Kaiseraugst, Switzerland) ad libitum
- Water: tap water ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Route of administration:

oral: gavage

Vehicle:

olive oil

Remarks:

DAB 10

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/kg: 4 g/100 ml; 2000 mg/kg: 40 g/100 ml
- Justification for choice of vehicle: the test substance cannot be homogenized in water

DOSE VOLUME APPLIED: 5 ml/kg

Doses:

200; 2000 mg/kg

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: A check for any dead or moribund animals was made twice each workday and once on Saturdays, Sundays and on public holidays. Clinical signs and symptoms were recorded several times on the day of administration, at least once each workday for the individual animals. Individual body weights were determined shortly before application (day 0), weekly thereafter and at the end of the study (before fasting period).
- Necropsy of survivors performed: yes

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality

Mortality:

No mortality.

Clinical signs:

other: Male animals: impaired general state, poor general state, dyspnoea, apathy, staggering, piloerection; Female animals: no abnormality.

Gross pathology:

No pathologic findings noted.

Symptoms of the male animals (cageside observations):

Dose (mg/kg)	200	No. of animals	2000	No. of animals
Impaired general state	H3-H5	3/3	H2-D1	3/3
Poor general state	H0-H2	3/3	H2-H3	1/3
Dyspnoea	H0-H5	3/3	H2-D1	3/3
Apathy	H0-H2	3/3	H2-H3	1/3
Staggering	H0-H2	3/3
Piloerection	H1-H5	3/3	H2-D1	3/3

H: Hour; D: Day

 

Individual body weights (g):

Dose	200 mg/kg	Weight day:	0	7	13
Males		01	186	265	309
		02	175	244	278
		03	179	260	297
Females		01	175	203	216
		02	175	208	224
		03	173	206	219
Dose	2000 mg/kg	Weight day:	0	7	13
Males		01	179	252	289
		02	175	242	280
		03	175	247	285
Females		01	186	223	230
		02	178	206	210
		03	177	214	231

 

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Conclusions:

Under the conditions of this study the median lethal dose of the test substance after oral application was found to be greater than 2000 mg/kg body weight for the male and female animals.

Executive summary:

The study was performed to assess the acute toxicity following oral administration of the test substance, applied as a suspension in olive oil DAB 10, in Wistar rats. The study procedure was based on the EEC gudeline and modified according to the acute toxic class method. To each group of six fasted animals (three males and three females) a single oral dose of the test material preparation in olive oil DAB 10 at dose levels of 200 and 2000 mg/kg body weight was given.

Signs of toxicity noted in male animals of the 200 and 2000 mg/kg dose groups comprised impaired or poor general state, dyspnoea, apathy and staggering. These symptoms are considered to be unspecific toxicity symptoms. The animals appeared normal within 2 days after application. The female rats of both dose groups did not show any signs of toxicity. The expected body weight gain was oberved in the course of the study. No mortality occured. No abnormalities were noted at necropsy of animals sacrificed at the end of the study.

Conclusion: Under the conditions of this study the median lethal dose of the test substance after oral application was found to be greater than 2000 mg/kg body weight for the male and female animals.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

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:

other: GLP guidleine study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Exception: Concentration control analyses of the test item preparation could not be performed. The absent value does not influence the results of this study.

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: Young adult animals (male animals approx. 8 weeks, female animals approx. 12 weeks)
- Mean weight ± SD at study initiation: males 258.4 ± 12.5, females 200.8 ± 3.11
- Housing: Single housing in Makrolon cages, type III
- Diet: VRF1(P) (SDS Special Diets Services, 67122 Altrip, Germany)
- Water: Tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Type of coverage:

semiocclusive

Vehicle:

olive oil

Details on dermal exposure:

TEST SITE
- Area of exposure: about 40 cm² clipped epidermis of the dorsal and dorsolateral parts of the trunk
- % coverage: at least 10% of the body surface
- Type of wrap if used: The test item was covered with an air-permeable dressing (4 layers of absorbent gauze (Ph. Eur. supplied by Lohmann GmbH & Co., KG) and stretch bandage (Fixomull Stretch (adhesive fleece) supplied by Beiersdorf AG).

REMOVAL OF TEST SUBSTANCE
- Washing: with warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 3.33 g/kg bw (because the test item preparation was a paste the application volume was determined by using a scale in g/kg bw).
- Concentration: 60 g/100 mL in olive oil
- Constant volume or concentration used: yes
- For solids, paste formed: yes

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: A check for any dead or moribund animals was made at least once each workday. Clinical signs were recorded several times on the day of administration, and at least once daily thereafter each workday for the individual animals. Individual body weights were determined shortly before administration (day 0), weekly thereafter and on the last day of observation. Individual skin findings were scored according to Draize 30 – 60 minutes after removal of the semi-occlusive dressing (day 1), weekly and on the last day of observation.
- Necropsy of survivors performed: yes

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

act. ingr.

Remarks on result:

other: no mortality

Mortality:

No mortality occurred.

Clinical signs:

other: No systemic clinical signs were observed during clinical examination.

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.

Other findings:

No local effects were observed.

INDIVIDUAL BODY WEIGHT CHANGES:

Dose (mg/kg bw):	2000
Sex:	male
Animal No.:	1	2	3	4	5	Mean weight	SD
Body weight at study day (g):
0	252	246	265	252	277	258.4	12.5
7	280	268	294	275	307	284.8	15.64
14	315	298	326	304	351	318.8	20.95
Dose (mg/kg bw):	2000
Sex:	female
Animal No.:	1	2	3	4	5	Mean weight	SD
Body weight at study day (g):
0	201	206	198	199	200	200.3	3.11
7	204	207	203	205	203	204.4	1.67
14	218	208	213	228	210	215.4	7.99

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Conclusions:

Under the conditions of this study the median lethal dose (LD50) of Polyglycerintribehenat after dermal application was found to be greater than 2000 mg/kg bw in male and female rats.

Executive summary:

The study was performed according to OECD guideline 402 in compliance with GLP.

In this acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of Polyglycerintribehenat (as paste in olive oil Ph.Eur.) to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours. The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days.

No mortality occurred. No signs of systemic toxicity or skin effects were observed in the animals. The mean body weight of the male animals increased within the normal range throughout the study period. The mean body weight of the female animals stagnated during the first post-exposure observation week, probably due to the bandage procedure, but increased during the second week within the normal range. No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.

 

Conclusion: Accordingly, the acute dermal median lethal dose (LD50) was determined to be LD50, dermal, rat > 2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

Acute oral toxicity

The key study (BASF AG, 1998) was performed to assess the acute toxicity following oral administration of the test substance, applied as a suspension in olive oil DAB 10, in Wistar rats. The study procedure was based on the EEC gudeline and modified according to the acute toxic class method. To each group of six fasted animals (three males and three females) a single oral dose of the test material preparation in olive oil DAB 10 at dose levels of 200 and 2000 mg/kg body weight was given.

Signs of toxicity noted in male animals of the 200 and 2000 mg/kg dose groups comprised impaired or poor general state, dyspnoea, apathy and staggering. These symptoms are considered to be unspecific toxicity symptoms. The animals appeared normal within 2 days after application. The female rats of both dose groups did not show any signs of toxicity. The expected body weight gain was oberved in the course of the study. No mortality occured. No abnormalities were noted at necropsy of animals sacrificed at the end of the study.

Under the conditions of this study the median lethal dose of the test substance after oral application was found to be greater than 2000 mg/kg body weight for the male and female animals.

Acute dermal toxicity

The key study was performed according to OECD guideline 402 in compliance with GLP (BASF SE, 2011). In this acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of Polyglycerintribehenat (as paste in olive oil Ph.Eur.) to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours. The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days.

No mortality occurred. No signs of systemic toxicity or skin effects were observed in the animals. The mean body weight of the male animals increased within the normal range throughout the study period. The mean body weight of the female animals stagnated during the first post-exposure observation week, probably due to the bandage procedure, but increased during the second week within the normal range. No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.

Accordingly, the acute dermal median lethal dose (LD50) was determined to be LD50, dermal, rat > 2000 mg/kg bw.

Justification for selection of acute toxicity – oral endpoint
only available reliable study

Justification for selection of acute toxicity – dermal endpoint
only available reliable study

Justification for classification or non-classification

Based on the results of the available acute toxicity studies the test item does not need to be subjected to classification and labelling according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP/GHS).