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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19 Jun - 05 Jul 1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
(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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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
Key result
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:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
CLP: not classified