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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
weight variation is higher than 20% of mean
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis(2-propylheptyl) phthalate
EC Number:
258-469-4
EC Name:
Bis(2-propylheptyl) phthalate
Cas Number:
53306-54-0
Molecular formula:
C28H46O4
IUPAC Name:
1,2-bis(2-propylheptyl) benzene-1,2-dicarboxylate
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
other: albino
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: between 2.0 and 3.0 kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: back of animal
- Preparation: All animals had their backs clipped free 24 h prior to testing. All of the animals had their backs abraded prior to dosing.
- Type of wrap if used: large gauze patches and an impervious wrap around the trunk


REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 24 h


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): 100%
- Constant volume or concentration used: no, corrected for body weight
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: prior to and at the end of study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
Clinical signs:
other: There were no unusual behavioral signs noted.
Gross pathology:
Gross pathologic examination revealed nothing remarkable.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met