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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03 July, 1980 - 04 August, 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well described short report. Dose, number of animals (with details), experimental design and observation period are described in the study. Performed in compliance with the FDA's GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Automatically generated during migration to IUCLID 6, no data available
IUPAC Name:
Automatically generated during migration to IUCLID 6, no data available
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Elintaal
- Description: Clear liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Perfection breeders
- Age at study initiation: approx. 9 weeks old
- Weight at study initiation: 2.1 - 2.5 kg
- Housing: Two animals per cage were housed in suspended wire mesh cages.
- Diet: Fresh Purina rabbit chow was freely available
- Water: Water was freely available
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature controlled
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Immediately prior to dosing, the fur was clipped from the abdomen of the animals.
- Area of exposure: 200 square cm
- % coverage: approx. 10% of the body surface
- Abrasions were made in 1/2 of the rabbits. The abrasions, extending the length of the exposure site, scratched the stratum corneum but did not reach the derma or produce bleeding.
- The patches were secured with adhesive tape and the trunks were wrapped with impervious material.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no, exposure site was wiped to remove excess material.

TEST MATERIAL
- Amount applied: the dose was based on the sample weight as calculated from the specific gravity.
Duration of exposure:
24 hours
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Dermal reactions were scored at 1, 7 and 14 days after removal of the patches.
The animals were observed daily for 14 days for signs of toxicity, clinical signs and mortality.
Body weights were recorded pretest and in the survivors at 14 days.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
Diarrhea and yellow nasal discharge was observed (in 2 animals).
Body weight:
Body weight findings were normal.
Gross pathology:
No abnormalities were observed.
Other findings:
Erythema was observed, slight/well defined on days 1 and 7, generally cleared by day 14.
Edema was observed, absent to severe on day 1, completely cleared on day 14.
Treated skin was found damaged in 2 animals at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute dermal toxicity with male rabbits, an LD50 >5000 mg/kg bw was determined.
Executive summary:

Elintaal was tested in an acute dermal toxicity study with male rabbits at 5000 mg/kg body weight. The study was performed equivalent to OECD 402 guideline and GLP principles. No deaths occurred. Diarrhea and yellow nasal discharge was observed.

Erythema was observed, slight/well defined on days 1 and 7, generally cleared by day 14. Edema was observed, absent to severe on day 1, completely cleared on day 14. Treated skin was found damaged in 2 animals at necropsy. Based on the results, an LD50 >5000 mg/kg bodyweight was determined.