Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Despite the low number of animals and the lack of gross pathological examination the evaluable report provided sufficient information to evaluate this endpoint.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Low number of animals in test and no necropsy is performed at the end of the observation time.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2-dimethylpropane-1,3-diyl dibenzoate
EC Number:
224-081-9
EC Name:
2,2-dimethylpropane-1,3-diyl dibenzoate
Cas Number:
4196-89-8
Molecular formula:
C19H20O4
IUPAC Name:
3-(benzoyloxy)-2,2-dimethylpropyl benzoate
Specific details on test material used for the study:
- yellowish white chunks

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2310-2381 g
- Housing: individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: 9 days

ENVIRONMENTAL CONDITIONS
- temperature and humidity controlled quarters
- The animals were maintained in accordance with the recommendations contained in H.E.W. Publication No.74-23 (N.I.H.) entitled "Guide for the care and use of laboratory animals"

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
physiological saline
Details on dermal exposure:
The test material was applied once only to the shaved backs of the rabbits at a dosage level of 20000 mg/kg bw for 24 hours. Physiological saline was used as a wetting agent.
Duration of exposure:
24 hours
Doses:
20000 mg/kg bw
No. of animals per sex per dose:
4
Control animals:
other: untreated area at the opposite site
Details on study design:
2 male and 2 female rabbits were used. The hair was removed from the back of the rabbits (20-30 % of the body surface) with an electric clipper. The skin of 2 rabbits was abraded. The test material was applied once only to the shaved backs of the rabbits at a dosage level of 20000 mg/kg bw for 24 hours. Physiological saline was used as a wetting agent. The opposite site of the treatment area served as control. The treated area were covered by semiocclusive dressing. After 24 hours of exposure the bandages were removed and animals were observed for mortality, clinical signs , body weight development and local effects at the treatment area up to 14 days post exposure.
Statistics:
no data

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 20 000 mg/kg bw
Remarks on result:
other: No rabbit died. All rabbits appeared normal and gained body weight. Some animals showed slight to very slight discoloration at the treated area, but recovered within the 14 day observation period.
Mortality:
No rabbit died.
Clinical signs:
other: All rabbits appeared normal.
Gross pathology:
Gross pathological examination was not performed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
2,2-dimethylpropane-1,3-diyl dibenzoate was applied once only to the shaved backs of the rabbits at a dosage level of 20000 mg/kg bw for 24 hours. No rabbit died. All rabbits appeared normal and gained body weight. Thus, the LD50 is > 20000 mg/kg bw.
Executive summary:

Despite the low number of animals and the lack of gross pathological examination the following examination is similar to the guideline of today and is valid for evaluation of this endpoint: To examine the acute dermal toxicity 2 male and 2 female rabbits were used. The hair was removed from the back of the rabbits (20-30 % of the body surface) with an electric clipper. The skin of 2 rabbits was abraded. The test material was applied once only to the shaved backs of the rabbits at a dosage level of 20000 mg/kg bw for 24 hours. Physiological saline was used as a wetting agent. The opposite site of the treatment area served as control. The treated area were covered by semiocclusive dressing. After 24 hours of exposure the bandages were removed and animals were observed for mortality, clinical signs, body weight development and local effects at the treatment area up to 14 days post exposure. No rabbit died. All rabbits appeared normal and gained body weight. Some animals showed slight to very slight discoloration at the treated area, but recovered within the 14 day observation period. Thus, the LD50 is > 20000 mg/kg bw.