Registration Dossier

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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24/48 h
Score:
0
Max. score:
4
Remarks on result:
other: 20 h exposure
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24/48 h
Score:
0
Max. score:
4
Remarks on result:
other: 20 h exposure
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24/48 h
Score:
0
Max. score:
4
Remarks on result:
other: 20 h exposure
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24/48 h
Score:
0
Max. score:
4
Remarks on result:
other: 20 h exposure
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
Remarks:
Migrated information
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.