Registration Dossier

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 study by OECD methods.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals 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 (e.g. ad libitum): Spratt's Rodent Breeding Diet (LAD 1), ad libitum
- Water (e.g. ad libitum): 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 light/12 hrs dark

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 (if done): 30-40 degree C water
- Time after start of exposure: 24 hrs


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 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, bodyweights were taken on days 1, 8, and 15
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No animals died during the study.
Clinical signs:
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.
Body weight:
Body weights were normal.
Gross pathology:
No abnormalities were noted at autopsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of LAB was greater than 2000 mg/kg.
Executive summary:

This study determined the acute dermal toxicity of the test substance in rats. 5 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.