3-hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropionate

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: The study is comparable to OECD Guideline 404 with acceptable restrictions (partly limited documentation, e.g. details about the test substance; exposure period 20 h and occlusive coverage conditions [worst case scenario]).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

20 h occlusive exposure

Principles of method if other than guideline:

Skin irritation was tested using an internal method (BASF test)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropionate

EC Number:

214-222-2

EC Name:

3-hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropionate

Cas Number:

1115-20-4

Molecular formula:

C10H20O4

IUPAC Name:

3-hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropanoate

Details on test material:

- Name of test material (as cited in study report): Hydroxypivalinsaeureneopentylglykolester (HPN)
- Physical state: solid
no further details

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

One females, initial weight: 2.61 and one male, initial weight 2.84 kg
no further details

Test system

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

water

Controls:

no

Amount / concentration applied:

80% test substance (w/v) in distilled water was used. The application site was covered with an cotton patch of 2.5 X 2.5 cm; prior application of the test substance to the patch, amount not reported (presumably patch soaked with the test substance); no further data.

Duration of treatment / exposure:

1, 5, or 15 minutes or 20 h

Observation period:

Results were recorded each working day for up to 7 days. Scoring was done 24 h, 48 h and 5 and 7 days after initiation.

Number of animals:

2 rabbits

Details on study design:

After the reported exposure time, the skin was washed with 50% Lutrol in water.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No effects were detected after 1, 5, or 15 minutes of exposure; no effects were seen after 20 h occlusive application (see Table below).
No edema was reported in any experiment.

Other effects:

Body weight not altered.

Any other information on results incl. tables

Skin erythema in 2 rabbits after dermal exposure to the undiluted test substance for 20 h followed by washing with 50% Lutrol

Time after initiation of exposure	20 hours exposure; erythema in
	Rabbit 1	Rabbit 2
24 h	0	0
48 h	0	0
5 days	0	0
7 days	0	0

Evaluation transformed to OECD-Draize scoring; no edema reported.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Conclusions:

The test substance has no skin irritant properties.

Executive summary:

The study is comparable to OECD Guideline 404 with acceptable restrictions (partly limited documentation, e.g. details about the test substance; exposure period 20 h and occlusive coverage conditions [worst case scenario]).

Two rabbits were dermally exposed to moistened test substance for 1, 5, 15 minutes or for 20 h. The coverage was occlusive; the skin was washed after exposure. Skin reaction was scored 24 & 48 h, and 5 and 7 days initiation. No erythema was found. No edema was reported.

Conclusion: The test substance has no skin irritant properties.