Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
limit test with 9 females, 1 male
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
not specified
Remarks:
Albino
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ace Animals (received on July 27 and August 24, 1982)
- Weight at study initiation: 1.9-2.5 kg
- Housing: 2 animals per cage in suspended wire mesh cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature controlled

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: abdomen
- % coverage: 10% of the body surface
- Type of wrap if used: gauze patch, wrapped wtih plastic, secured with tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the site was wiped
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): between 11.6-14.0 ml
- Concentration (if solution): 0.82 g/ml
- Constant volume or concentration used: yes
Duration of exposure:
24 hours
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
9 females, 1 male
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 24 hours post dose and on days 7 and 14 for mortality, toxicity and pharmacological effect.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No animals died.
Clinical signs:
Dermal reactions (erythema and edema) were slight to moderate observed on day 1, severe on day 7, and minimal on dag 14.
Physical signs observed were: Alopecia, diarrhea, few feces, yellow nasal discharge, ptosis.
Body weight:
Body weight changes were normal for 7/10 rabbits. Three rabbits, which had exhibited diarrhea and/or few faces, lost weight.
Gross pathology:
No abnormalities were found on the internal organs on superficial examination for 7/10 rabbits. Of the remaining 3 animals, alopecia adjacent to the treated site and intestinal abnormalities were noted.

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
according to EU CLP criteria (EC 1272/2008 and its updates)
Conclusions:
Under the conditions of this test, an acute dermal LD50 of >5000 mg/kg bw was determined for Tetrahydromyrcenol.
Executive summary:

An acute dermal toxicity study was performed according to a method similar to OECD TG 402. In this study, 10 healthy albino rabbits were dosed dermally with Tetrahydromyrcenol at 5000 mg/kg bw of body weight. The test article was kept in contact with the skin for 24 hours. All rabbits survived the 5000 mg/kg bw dermal dose. Physical signs noted in 3 or more rabbits included yellow nasal discharge, diarrhea, alopecia and few feces. Dermal responses, slight to moderate on Day 1, were severe on Day 7 and minimal on Day 14. Body weight changes were normal for 7/10 rabbits. Three rabbits, exhibited diarrhea and/or few feces, lost weight. The internal organs on superficial examination appeared normal for 7/10 rabbits. Of the remaining 3 animals, alopecia adjacent to the treated site and intestinal abnormalities were noted. Under the conditions of this test, an acute dermal LD50 of >5000 mg/kg bw was determined for Tetrahydromyrcenol.