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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
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:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Dodecanedioic acid
EC Number:
211-746-3
EC Name:
Dodecanedioic acid
Cas Number:
693-23-2
Molecular formula:
C12H22O4
IUPAC Name:
dodecanedioic acid

Test animals

Species:
rabbit
Strain:
other: albino rabbits
Sex:
male
Details on test animals or test system 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:
No animal died during the study
Clinical signs:
other: 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.

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:
Based on a read across (category approach), no classification regarding acute dermal toxicity is required for tetradecanedioic acid.