1,2,3-Propanetriol, homopolymer, docosanoate

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:

other: GLP guidleine study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2012

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

1,2,3-Propanetriol, oligomers, docosanoate

EC Number:

613-583-7

Cas Number:

64366-79-6

Molecular formula:

C22 H44 O2 . x (C3 H8 O3)x

IUPAC Name:

1,2,3-Propanetriol, oligomers, docosanoate

Details on test material:

- Name of test item: Polyglycerintribehenat
- Batch identification: 78865309T0 (Partie 295)
- CAS No.: 64366-79-6
- Purity: nearly 100 %
- Homogeneity: The test item was homogeneous by visual inspection.
- Storage stability: The stability of the test item under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
- Storage conditions: Room temperature; under light exclusion
- Physical state/ color: Solid, melt / yellowish

Test animals

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

Administration / exposure

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

Results and discussion

Effect levels

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.

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.