Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
In vivo study
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May 1973
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO)
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Russian breed- Weight at study initiation: 1.8 to 2.9 kg- Housing: single housed in metal cage (overall dimensions 47x32x34 cm)- Diet: standard diet of Nafag ad libitum- Water: drinking water ad libitum- Acclimation period: 8 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 18 ± 1°C- Humidity (%): 55 ± 5 %- Photoperiod (hrs dark / hrs light): 14 hours light/day

Test system

Type of coverage:
not specified
Preparation of test site:
other: shaved and abraded
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL- Amount applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
24 hours
Observation period:
10 days
Number of animals:
3 males and 3 females rabbit
Details on study design:
TEST SITE- Area of exposure: 2.5 X 2.5 cm- Type of wrap if used: A gauze patch of 2.5 x 2.5 cm laden with test substance was applied immediately to the prepared skin. The patch was covered with an impermeable foil of 5 x 5 cm, which was fixed to the body of the animals with adhesive tape.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 38
Time point:
other: 24, 48, 72 hours
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: shaved skin
Irritation parameter:
erythema score
Basis:
animal: 40
Time point:
other: 24, 48, 72 hours
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: shaved skin
Irritation parameter:
erythema score
Basis:
animal: 42
Time point:
other: 24, 48, 72 hours
Score:
ca. 0.66
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: shaved skin
Irritation parameter:
erythema score
Basis:
animal: 29
Time point:
other: 24, 48, 72 hours
Score:
ca. 0
Max. score:
4
Reversibility:
other: No skin reaction observed
Remarks on result:
other: shaved skin
Irritation parameter:
erythema score
Basis:
animal: 31
Time point:
other: 24, 48, 72 hours
Score:
ca. 0
Max. score:
4
Reversibility:
other: No skin reaction observed
Remarks on result:
other: shaved skin
Irritation parameter:
erythema score
Basis:
animal: 33
Time point:
other: 24, 48, 72 hours
Score:
ca. 0
Max. score:
4
Reversibility:
other: No skin reaction observed
Remarks on result:
other: shaved skin
Irritation parameter:
edema score
Basis:
animal: 38
Time point:
other: 24, 48, 72 hours
Score:
ca. 0
Max. score:
4
Reversibility:
other: No skin reaction observed
Remarks on result:
other: shaved skin
Irritation parameter:
edema score
Basis:
animal: 40
Time point:
other: 24, 48, 72 hours
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: shaved skin
Irritation parameter:
edema score
Basis:
animal: 42
Time point:
other: 24, 48, 72 hours
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: shaved skin
Irritation parameter:
edema score
Basis:
animal: 29
Time point:
other: 24, 48, 72 hours
Score:
ca. 0
Max. score:
4
Reversibility:
other: No skin reaction observed
Remarks on result:
other: shaved skin
Irritation parameter:
edema score
Basis:
animal: 31
Time point:
other: 24, 48, 72 hours
Score:
ca. 0
Max. score:
4
Reversibility:
other: No skin reaction observed
Remarks on result:
other: shaved skin
Irritation parameter:
edema score
Basis:
animal: 33
Time point:
other: 24, 48, 72 hours
Score:
ca. 0
Max. score:
4
Reversibility:
other: No skin reaction observed
Remarks on result:
other: shaved skin

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
not classified according to CLP Regulation (EC n. 1272/2008)
Conclusions:
Under the conditions of this experiment preparation the test item was found non irritating when applied to intact or abraded rabbit skin.
Executive summary:

The substance has been tested for skin irritation according to patch test technique as described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). The substance was applied to shaved and abraded skin of 6 rabbits. Before application the test material was wetted with tap water. The gauze patches were removed 24 hours after application. The reaction of the skin was appraised upon removal during an observation period of 10 days. Under the conditions of this experiment preparation the test item was found non irritating when applied to intact or abraded rabbit skin.