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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1)
Cross-reference
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Justification for type of information:
Refer to section 13 of IUCLID for details on the read-across justification. The study with the read across substance is considered sufficient to fulfil the information requirements.
Reason / purpose for cross-reference:
read-across source
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
yes
Remarks:
1. In the study, abraded and non abraded skin sites were used; however, the guideline recommends unabraded skin. 2. Exposure period was 24 h; however, guideline recommends 4 h exposure period
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Type of coverage:
occlusive
Preparation of test site:
other: The test substance was applied to both abraded and intact skin
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Test material
- Amount(s) applied (volume or weight with unit): 0.5 mL


Duration of treatment / exposure:
24h
Observation period:
24 and 72h
Number of animals:
6
Details on study design:
Test site:
- Area of exposure: Back of animal
- Type of wrap if used: The patches consisted of two layers of light gauze cut in squares (2.5 cm on the side). The patches were secured to the test area by thin bands of adhesive tape and the trunk of each animal was wrapped in clear plastic trunk bands after application of the test substance.
- Type of test site: Two areas (intact and abraded) on the back of each animal placed approximately 10 cm apart

Scoring system:
- Skin reactions were scored for erythema and edema, according to Draize Woodland and Calvery scoring system.
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24h and 72h
Score:
6.29
Max. score:
8
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: Intact and abraded skin site
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h and 72h
Score:
3.33
Max. score:
4
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: Intact skin site
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h and 72h
Score:
3.5
Max. score:
4
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: Abraded skin site
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h and 72h
Score:
2.66
Max. score:
3
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: Intact skin site
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h and 72h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: Abraded skin site
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24/72 h
Score:
ca. 3.5 - ca. 4
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
positive indication of irritation
Remarks:
(mean erythema score was: 3.5 for intact and 4 for abraded skin)
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 / 72 h
Score:
ca. 3 - ca. 3.5
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
positive indication of irritation
Remarks:
(mean erythema score was: 3 for intact and 3.5 for abraded skin)
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24 / 72 h
Score:
ca. 3.5
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
positive indication of irritation
Remarks:
(mean erythema score was: 3.5 for intact and 3.5 for abraded skin)
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 24 / 72 h
Score:
ca. 3.5
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
positive indication of irritation
Remarks:
(mean erythema score was: 3.5 for intact and 3.5 for abraded skin)
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 24 / 72 h
Score:
ca. 3
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
positive indication of irritation
Remarks:
(mean erythema score was: 3 for intact and 3 for abraded skin)
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 24 / 72 h
Score:
ca. 3.5 - ca. 4
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
positive indication of irritation
Remarks:
(mean erythema score was: 4 for intact and 3.5 for abraded skin)
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 / 72 h
Score:
ca. 2.5 - ca. 3
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
positive indication of irritation
Remarks:
(mean erythema score was: 2.5 for intact and 3 for abraded skin)
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24 / 72 h
Score:
ca. 2.5 - ca. 3
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
positive indication of irritation
Remarks:
(mean erythema score was: 2.5 for intact and 3 for abraded skin)
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24/72 h
Score:
ca. 3
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
positive indication of irritation
Remarks:
(mean erythema score was: 3 for intact and 3 for abraded skin)
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 24/72 h
Score:
ca. 2.5 - ca. 3
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
positive indication of irritation
Remarks:
(mean erythema score was: 2.5 for intact and 3 for abraded skin)
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 24/72 h
Score:
ca. 3
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
positive indication of irritation
Remarks:
(mean erythema score was: 3 for intact and 3 for abraded skin)
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: 24/72 h
Score:
ca. 2.5 - ca. 3
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
positive indication of irritation
Remarks:
(mean erythema score was: 2.5 for intact and 3 for abraded skin)
Irritation parameter:
erythema score
Time point:
24/48/72 h
Remarks on result:
other: see below table for details on results
Irritation parameter:
edema score
Time point:
24/48/72 h
Remarks on result:
other: see below table for details on results
Irritant / corrosive response data:
- Severe erythema and edema were observed in animals with abraded and intact skin. See below table for individual animal scores at each time point.

Table 1. Individual animal data on the skin irritation response

Rabbit no.

Reaction

24 h

72 h

Intact

Abraded

Intact

Abraded

1

Erythema

4

4

3

4

Edema

2

3

3

3

2

Erythema

3

4

3

3

Edema

2

3

3

3

3

Erythema

4

4

3

3

Edema

3

3

3

3

4

Erythema

4

4

3

3

Edema

2

3

3

3

5

Erythema

3

3

3

3

Edema

3

3

3

3

6

Erythema

4

4

4

3

Edema

2

3

3

3

 

Interpretation of results:
other: Category 1B (corrosive) based on CLP criteria
Conclusions:
Based on the results of the read across study, the test substance, C12 ADBAC, can be considered to be corrosive to rabbit skin.
Executive summary:

A study was conducted to determine the skin irritation / corrosion potential of the read across substance, C12 -16 ADBAC (50 -80% active), according to US EPA OPPTS 870.2500. The experiment was performed in rabbits. The undiluted test substance was applied on intact and abraded skin sites using occlusive patches for an exposure period of 24 h. The skin was then observed for erythema and edema formation and the scoring was done according to the Draize, Woodland and Calvery scoring system at 24 and 72 h from the onset of exposure. Severe erythema and edema were observed in all the test animals at both the abraded and intact sites. The mean Primary Irritation Index (PII) of the test substance was calculated to be 6.29 and the mean values of erythema and edema were 3.33 (intact skin site), 3.5 (abraded skin site), 2.66 (intact skin site) and 3 (abraded skin site). Under study conditions, C12 -16 ADBAC is considered to be corrosive to rabbit skin (Wallace, 1975). Based on the results of the read across study, the test substance, C12 ADBAC, can be considered to be corrosive to rabbit skin.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion