Pentaerythritol, mixed esters with linear and branched fatty acids

Acute Toxicity: dermal

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Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

19 Jun - 05 Jul 1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study with acceptable restriction (limited data on test material)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

adopted in 1987

Deviations:

yes

Remarks:

no information on the analytical purity of the test substance given

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Physical state: yellow liquid
- Lot/batch No.: 96012
- Expiration date of the lot/batch: 01.01.2006
- Storage condition of test material: at room temperature
- Analytical purity: neat (not further specified)

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HRP, Inc., Denver, Pennsylvania
- Age at study initiation: at least 8 weeks
- Weight at study initiation: males: 2.4-3.1 kg, females: 2.5-2.7 kg
- Housing: individually in suspended, stainless steel cages with wire mesh bottoms
- Diet: Lab Rabbit Diet HF, No 5326 and No 5326, ad libitum
- Water: ad libitum
- Acclimation period: males 58 d, females 60 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-21
- Humidity (%): 40-60
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 12 cm x 14 cm, clipped area of the dorsal trunk
- % coverage: approx. 10%
- Type of wrap if used: gauze secured with tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiping with distilled water
- Time after start of exposure: 24 h

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality: twice daily; dermal examination: 1, 24, 48 and 72 h after bandage removal and on Day 8 and 15 (males) or once only on Day 8 (females); clinical signs of toxicity: 1, 2 and 4 h after dosing and daily thereafter for 14 days; body weight: Day 0, 1, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: food consumption: daily

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

No clinical signs of toxicity were observed up to the end of the 14-day observtion period.

Body weight:

At the end of the study, 1 male and all 5 females showed no gain in body weight whereas the 4 remaining males lost weight over the whole study period (about -0.1 kg).

Gross pathology:

Necropsy revealed no substance-related findings.

Other findings:

None of the animal showed dermal irritation.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified