branched-nonyl 3,5,5 trimethylhexanoate

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 for cross-reference:

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

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

Materials and methods

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): Isononyl Isononanoate
- Physical state: liquid

Results and discussion

In vivo

Results

Results 1

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)

Results 2

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: 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)

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).