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Diss Factsheets

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
Before 9 Oct 2017
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
LAB
IUPAC Name:
LAB

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hacking and Churchill Limited
- Age at study initiation: 6 - 8 weeks
- Weight at study initiation: 206 - 250 g
- Housing: individually in metal cages, identified by cage number and ear punching
- Diet: Spratt's Rodent Breeding Diet (LAD 1), ad libitum
- Water: Purified water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hrs

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorso-lumbar region
- coverage: 10%
- Type of wrap if used: gauze held in place with impermeable dressing over the trunk

REMOVAL OF TEST SUBSTANCE
- Washing: 30 - 40 °C water
- Time after start of exposure: 24 hrs

TEST MATERIAL
- Amount applied: 2.0 g/kg bw
Duration of exposure:
24 hrs
Doses:
2.0 g/kg bw
No. of animals per sex per dose:
5 male and 5 females
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations - twice daily for mortality and signs of toxicity, daily for skin observations, body weights were taken on days 1, 8, and 15
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No animals died during the study.
Clinical signs:
other: Nine of the animals developed a slightly raised red area at the dose site on day 6. Scabs formed at this area by day 9. All animals were fully recovered by the end of the experiment.
Gross pathology:
No abnormalities were noted at autopsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of the test substance was greater than 2000 mg/kg.
Executive summary:

This study determined the acute dermal toxicity of the test substance in rats. Five male and 5 female rats were exposed to 2000 mg/kg bw of test substance dermally. Exposure lasted 24 hrs, after which the test substance was removed by washing. The animals were observed for the next 14 days for clinical signs and mortality. All animals were necropsied at the end of the experiment. No animals died during the study. The dermal LD50 in rats is > 2000 mg/kg bw. The test substance is not classified as a dermal toxicant under EU GHS guidelines.

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