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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
Study period:
2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: glittery semi-liquid
Details on test material:
Colour: orange

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
During the test, the animals (males) weighed 1.92 kg and 2.47 kg. At the beginning of the test, the animals were 10-11 weeks old.

Each animal was kept in an individual box installed in conventional air conditioned animal husbanding.
The temperature and relative humidity of the main test were controlled to remain within target ranges of 17 to 23°C and 30 to 70%, respectively.
The rate of air exchange was approximately thirteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (07.00 to 19.00) and twelve hours darkness.
Drinking water and foodstuff were supplied freely.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: On the opposite flank an untreated area was served as the control.
Amount / concentration applied:
The test item C.A.E. Code: 8500010 was applied, as supplied, at the dose of 0.5 mL.
Duration of treatment / exposure:
The undamaged skin area of one flank of each animal was exposed during 4 hours.
Observation period:
The skin reactions were appreciated 1 hour and then 24, 48 and 72 hours after removal of the patch.
If no reaction is observed 72 hours after treatment the study is terminated. In case of persistent reactions, additional observations can be carried out from D7 to D14 in order to determine the reversible character of the lesions observed.
Number of animals:
3 animals were treated sequentially.
Initially, a single animal was treated. After considerations of the cutaneous responses produced in the first animal on day 14, two additional animals were treated during 4 hours in the same experimental conditions.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 1.7
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other:
Remarks:
see conclusions
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other:
Remarks:
see conclusions
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other:
Remarks:
see conclusions
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 1.3
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other:
Remarks:
see conclusions
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0.3
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other:
Remarks:
see conclusions
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0.3
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other:
Remarks:
see conclusions
Irritant / corrosive response data:
A well defined erythema was noted on the treated area, 1 hour after the patch removal, and was totally reversible on day 7. A slight oedema was noted on the treated area, 1 hour after the patch removal, and was totally reversible between days 3 and 7.
On the cutaneous structure, dryness of the skin was noted from day 3 in one animal and from day 7 in two animals. The skin recovered a normal aspect on day 14 in two animals but the dryness of the skin was still noted on day 14 in one rabbit (end of the observations).
Other effects:
None.

Any other information on results incl. tables

 OBSERVATIONS

          INDIVIDUAL DATA

 Skin reactions  Observation time  Animal 1  Animal 2  Animal 3
 Erythema and eschar        24 hours  2  1  1
 48 hours  2  1  1
 72 hours  1  1  1
 MEAN     1.7  1.0  1.0
 Oedema        24 hours
48 hours 
72 hours   1  0
 MEAN     1.3 0.3   0.3

 

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The results obtained, in these experimental conditions, enable to conclude that the test item C.A.E. Code: 8500010 must not be classified, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59 and 1999/45. No symbol or risk phrase is required.

In accordance with the Regulation (EC) No.1272/2008, the test item must not be classified. No signal word or hazard statement is required.
Executive summary:

The test item C.A.E. Code: 8500010 was applied, as supplied, at the dose of 0.5 mL, under semi-occlusive dressing during 4 hours on an undamaged skin area of three New Zealand rabbits. The experimental protocol was established according to the OECD guideline No.404 dated April 24th, 2002 and the test method B.4 of the Council regulation No.440/2008 of 30 May 2008.

 

A well defined erythema was noted on the treated area, 1 hour after the patch removal, and was totally reversible on day 7. A slight oedema was noted on the treated area, 1 hour after the patch removal, and was totally reversible between days 3 and 7.

On the cutaneous structure, dryness of the skin was noted from day 3 in one animal and from day 7 in two animals. The skin recovered a normal aspect on day 14 in two animals but the dryness of the skin was still noted on day 14 in one rabbit (end of the observations).

 

The results obtained, in these experimental conditions, enable to conclude that the test item C.A.E. Code: 8500010 must not be classified, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59 and 1999/45. No symbol or risk phrase is required.

 

In accordance with the Regulation (EC) No.1272/2008, the test item must not be classified. No signal word or hazard statement is required.