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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
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: Basic data given. Test substance purity not given.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted in 1992
Deviations:
yes
Remarks:
purity of test substance not given, only basic data given
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Bis(2-octyldodecyl) adipate
EC Number:
285-645-8
EC Name:
Bis(2-octyldodecyl) adipate
Cas Number:
85117-94-8
IUPAC Name:
bis(2-octyldodecyl) adipate
Details on test material:
- Name of test material (as cited in study report): adipate d'octyldodecyle
- Lot/batch No.: Code 13015 - Batch 0401 G
- Purity: not given

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
other: not required, untreated sites of the same animal served as control
Amount / concentration applied:
no data
Duration of treatment / exposure:
no data
Observation period:
5 days (reading time points: 1, 24, 48 and 72 h and day 5)
Number of animals:
3
Details on study design:
Scoring was performed according to Draize.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
Erythema graded 1 was seen in one animal at reading time point 48 and 72 h whereas in a further animal, the same finding was reported at 24, 48 and 72 h. In both cases, full reversibility was completed on day 5. The third animal showed no erythema, and none of the 3 animals showed edema.

Applicant's summary and conclusion

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