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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Cross-reference
Reason / purpose:
read-across source
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions. The exposure time was 24 h, no experimental 48 h reading performed, occlusive exposure, the analytical purity of the test substance was not specified.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
24-h exposure time, no experimental 48 h reading, occlusive exposure
GLP compliance:
not specified
Species:
rabbit
Strain:
other: New Zealand
Type of coverage:
occlusive
Preparation of test site:
other: shaved and abraded
Vehicle:
unchanged (no vehicle)
Controls:
other: not required, untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
Duration of treatment / exposure:
24 h
Observation period:
72 h
Reading time points: 24 and 72 h
Number of animals:
6 males
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 6 animals, mean over 24, 48 and 72 h
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: No 48 h values are available: for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 6 animals, mean over 24, 48 and 72 h
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Remarks on result:
other: No 48 h values are available: for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
Irritant / corrosive response data:
Intact skin:
In 6/6 rabbits, very slight to weel defined erythema was noted at the 24-hour reading time point. The skin irritation effects were completely reversible within 72 h. No edema was observed in any animal.

Abraded skin:
In 6/6 rabbits, very slight to well defined erythema was noted at the 24-hour reading time point. The skin irritation effects were completely reversible within 72 h. No edema was observed in any animal.

Table 1. Results of skin irritation study – intact skin

Observation time

Rabbit no.

 

1

2

3

4

5

6

 

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

 

24 h

2

0

1

0

1

0

1

0

1

0

1

0

 

48 h

No experimental values available;for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption)

 

72 h

0

0

0

0

0

0

0

0

0

0

0

0

 

 

Table 2. Calculation of mean scores

 

Rabbit no.

 

1

2

3

4

5

6

 

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

 

Mean value 24 + 48 + 72 h*

1.33

0.00

0.67

0.00

0.67

0.00

0.67

0.00

0.67

0.00

0.67

0.00

 

 

 

* No 48 h values are available: for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects over 24 h and 48 h)

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

Data source

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Isononyl Isononanoate
- Physical state: liquid

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
mean over 24,48 and 72h
Time point:
24/48/72 h
Score:
ca. 0.7
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
other: No 48 h values are available: for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
Irritation parameter:
edema score
Basis:
mean
Remarks:
mean 24, 48, 72h
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: reversibility not applicable
Remarks on result:
other:

Applicant's summary and conclusion

Conclusions:
Based on the weight of evidence of all available data, isononyl isononanoate is not considered to be irritating to the skin.
Executive summary:

A human patch test with isononyl isononanoate is available, indicating no skin irritation potential in human volunteers (Gibaud, 2004). Furthermore, read-across from the structurally related substance 3,5,5-trimethylhexyl 3,5,5-trimethylhexanoate (CAS 59219-71-5) indicates no skin irritating potential in rabbits (Masson, 1986).