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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
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.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
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

Test material

Constituent 1
Chemical structure
Reference substance name:
3,5,5-trimethylhexyl 3,5,5-trimethylhexanoate
EC Number:
261-665-2
EC Name:
3,5,5-trimethylhexyl 3,5,5-trimethylhexanoate
Cas Number:
59219-71-5
Molecular formula:
C18H36O2
IUPAC Name:
3,5,5-trimethylhexyl 3,5,5-trimethylhexanoate
Details on test material:
- Name of test material (as cited in study report): Isononyl isononanoate
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
other: New Zealand

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
ca. 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
Time point:
24/48/72 h
Score:
ca. 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)
Remarks:
: 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 well defined erythema was noted at the 24-hour reading time point (score 1-2). 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 (score 1-2). The skin irritation effects were completely reversible within 72 h. No edema was observed in any animal.

Any other information on results incl. tables

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)

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

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