Registration Dossier

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: Study well documented, meets generally accepted scientific principles, acceptable for assessment, however only summary available, no GLP

Data source

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

Materials and methods

Principles of method if other than guideline:
see Test Conditions
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Dodecanedioic acid, purity 100 %

Test animals

Species:
rabbit
Strain:
other: albino rabbits
Sex:
male
Details on test animals and environmental conditions:
TEST ORGANISMS: 
- Strain: unspecified albino
- Weight at study initiation: 2.9-3.2 kg, mean 2.959 kg
- Controls: no

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
ADMINISTRATION: 
- Area covered: trunk area (back) clipped free of hair; plastic collars
- Preparation of test substance: moistened with physiological saline
- Occlusion: Three 3" x 3" 12 ply gauze pads; under wrap plus gauze  bandage; fixed with adhesive bandage
- Removal of test substance: 24 hours after administration washing with  water and drying
Duration of exposure:
24 hours
Doses:
6000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
not specified
Details on study design:
EXAMINATIONS: 14-day recovery period
OTHER: The dose was based on a range finding study with 1 rabbit each  dosed 5000 or 7500 mg/kg bw. There was difficulty adhering
7500 mg/kg bw  to the rabbit's back. Both rabbits survived.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 6 000 mg/kg bw
Mortality:
MORTALITY: No animal died during the study
Clinical signs:
CLINICAL SIGNS: slight skin irritation, diarrhea and nasal discharge. Two  rabbits had weight loss on the day after dosing and there was sporadic 
 weight loss 3-13 days after dosing. .
Body weight:
The mean body weight increased from  2.959 to 3.353 kg

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: EC Regulation 1272/2008
Conclusions:
no classification regarding acute dermal toxicity required
Executive summary:

In a limit test on dermal toxicity six male albino rabbits received a dose of 6000 mg/kg bw applied to the back skin for 24 hours. No mortalities occurred and observed effects included slight skin irritation, diarrhea, nasal discharge and sporadic weight loss.