3,5,5-trimethylhexyl 3,5,5-trimethylhexanoate

Skin irritation / corrosion

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

Test material information

Constituent 1

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

Results

Results 1

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)

Results 2

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