Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
3rd July 1980 to 1st August 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test substance was applied once to the clipped skin of New Zealand white rabbits at 5 g/kg over approximately 10 % of the body surface. Abrasions were made in half of the rabbits and extended the length of the exposure site, scratching only the strarum corneum, but did not reach the derma or produce bleeding. The area was covered with an occlusive dressing for 24 h after which the wrapping was removed and the exposed area was wiped, but not washed, to remove excess material. Dermal reactions were scored at 1, 7 and 14 days according to Draize. The rabbtis were observed daily for 14 days for signs of toxicity, pharmacological effects and mortality. All animals were examined for gross pathology at termiantion.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Bourgeonal
- Physical state: Clear liquid
- Other: Specific gravity = 0.94

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Perfection Breeders, Nicholas Helf
- Age at study initiation: approximately 8 weeks old
- Weight at study initiation: 2.3 - 2.6 kg
- Housing: 2/ cage in suspended wire mesh cages
- Diet (e.g. ad libitum): Purina rabbit chow ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 1 week

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Back
- % coverage: 10 %
- Type of wrap if used: Gaize patches secured with adhesive tape and the trunks were wrapped with impervious material.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washing was not done but the test area was wiped to remove excess test material.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 g/kg. The dose was based on the sample weight as calculated from the specific gravity.
- Constant volume or concentration used: No, volume ranged from 12.2 to 13.8 cc.
- For solids, paste formed: Not applicable, test material is a liquid
Duration of exposure:
Single exposure; the test material was not removed.
Doses:
5 g/kg
No. of animals per sex per dose:
6 females
Control animals:
no
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. The rabbits were scored daily for 14 days for signs of toxicity, pharmacological effects and mortality. Bodyweights were recorded pre-test and in the survivors at 14 days.
- Necropsy of survivors performed: Yes, all animals were examined for gross pathology.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 other: g/kg
Based on:
test mat.
Mortality:
There was one death at Day 4.
Clinical signs:
In the rabbit that died, pre-death toxic signs were diarrhoea, tachypnea, prostration, flaccid muscle tone and spasm.
Toxic sings in survivors included lethargy and diarrhoea.
Slight to moderate erythema was noted on Days 1 and 7 and was absent or slight on Day 14.
Body weight:
There was a slight loss in body weight in 4 out of 5 surviving animals.
Gross pathology:
Necropsy findings of survivors were normal. The spontaneous death had lung abnormalities.

Applicant's summary and conclusion

Conclusions:
The test substance was assessed for acute dermal toxicity in New Zealand white rabbits. There were no treatment-related deaths therefore the LD50 was > 5.0 g/kg.