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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
11 - 18 Mar 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions. The exposure was performed under occlusive conditions, the analytical purity of the test substance was not specified.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
occlusive exposure
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Fatty acids, C8-10, C12-18-alkyl esters
EC Number:
306-082-7
EC Name:
Fatty acids, C8-10, C12-18-alkyl esters
Cas Number:
95912-86-0
IUPAC Name:
95912-86-0
Details on test material:
- Name of test material (as cited in study report): coco caprylate/caprate
- Analytical purity: no data
- Physical state: clear liquid
- Lot/batch No.: 0907 D

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated skin site of the same animal served as the control
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
72 h
Reading time points: 1, 24, 48 and 72 h
Number of animals:
3 males
Details on study design:
TEST SITE
- Type of wrap if used: occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated site was not washed after patch removal

SCORING SYSTEM: Draize scoring system

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:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
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:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal #2
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:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibilty not applicable
Irritant / corrosive response data:
1 hour after exposure, all the animals had slight to well-defined erythema, while 2/3 had very slight to slight edema. These effects gradually reduced in severity. 24 hours after exposure ended, 1/3 animals had very slight erythema and slight edema. the edema persisted until the 48-hour reading time point.All skin irritation effects had cleared completely within 72 hours after the exposure ended.

Any other information on results incl. tables

Table 1: Erythema and edema scores for skin irritation of the individual animals at different reading time points:

Observation time

Rabbit no.

1

2

3

Erythema

Edema

Erythema

Edema

Erythema

Edema

1 h

2

2

1

0

1

1

24 h

1

2

0

0

0

0

48 h

0

1

0

0

0

0

72 h

0

0

0

0

0

0

Mean value 24 + 48 + 72 h

0.33

1.00

0

0

0

0

Mean value 24 + 48 + 72 h all animals

0.11

0.33

 

 

 

 

Applicant's summary and conclusion

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