Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions. Limited details on experimental conditions and test animals. Insufficient number of test animals. Mixed genders at each dose level. Occlusive dressing was used.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1972
Report date:
1972
Reference Type:
secondary source
Title:
ECB IUCLID set dihexyl adipate
Author:
ECB
Year:
2000
Bibliographic source:
EUROPEAN COMMISION – European Chemicals Bureau
Report date:
2000

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
limited details on experimental conditions and test animals; insufficient number of test animals; mixed genders at each dose level; occlusive dressing was used
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Dihexyl adipate
EC Number:
203-757-7
EC Name:
Dihexyl adipate
Cas Number:
110-33-8
Molecular formula:
C18H34O4
IUPAC Name:
dihexyl adipate
Details on test material:
- Name of test material (as cited in study report): Di-m-Hexyl adipate
- Physical state: liquid
- Analytical purity: no data

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: 1.9 and 2.1 kg (males), 1.9 and 2.2 kg (females)
- Housing: Animals were housed individually during the observation period.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: closely clipped area of the skin
- Type of wrap if used: The treated areas were covered with plastics strips and animals were held in wooden stocks during the exposure period.
Duration of exposure:
up to 24 h
Doses:
3160, 5010 and 7940 mg/kg bw
No. of animals per sex per dose:
3160 mg/kg bw: 1 female
5010 mg/kg bw: 1 male
7940 mg/kg bw: 1 male and 1 female
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 7 940 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the 14-day observation period.
Clinical signs:
Clinical signs involved reduced appetite and decreased activity 2 to 4 days after test substance application.
Body weight:
Five days after exposure, weight gain (+ 0.1 g) was observed in animals of the 3160 and 5010 mg/kg bw dose group. In contrast, a slight reduction in body weight (-0.1 g) was observed in the animals treated with 7940 mg/kg bw.
Gross pathology:
At necropsy, no macroscopic findings were observed in the viscera.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified