Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
An in vitro skin irritation study does not need to be conducted because adequate data from an in vivo study are available.
Type of information:
other: read across from supporting substance
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965).
GLP compliance:
no
Remarks:
Study conducted before 1981

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vitro test system

Control samples:
yes, concurrent no treatment

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: Porton
- Age at study initiation: 9-15 weeks
- Weight at study initiation: 2.44 Kg (♂), 2.10 kg (♀)
- Housing: Bred oh the premises and maintained under a semi-barrier system.
- Diet: A commercial irradiated diet (Styles-Oxoid) was fed ad lib.
- Water: Sterile filtered water was available at all times.
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1°C
- Humidity (%): 50-70 %
- Photoperiod (hrs dark / hrs light): Animals were exposed to artificial light for 10 hours daily from 08:00 - 18.00 hours.

Test system

Type of coverage:
not specified
Preparation of test site:
other: shaved and abraded
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 10 g of the test compound was mixed with 10 ml of water to make a solution of 15 ml, 0.75 ml of which was applied to each test site
Duration of treatment / exposure:
24 hours
Observation period:
24 and 72 hours
Number of animals:
Six rabbits (5 ♂ and 1 ♀)
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 10 % of the total body surface.
- Type of wrap if used: The site were covered with aluminium foil secured with "Sleek" adhesive tape. The test sites were then enclosed by a 6" wide "Coban" self adhesive bandage the edges of which were fixed to the skin by strips of "Sleek" in order to retain the test substance in close contact with the skin.

SCORING SYSTEM: Draize et al.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 11, 12, 13, 14, 15
Time point:
other: mean score after 24, 48 and 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: 16
Time point:
other: mean score after 24, 48 and 72 hours
Score:
ca. 0.66
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: shaved skin
Irritation parameter:
edema score
Basis:
animal: 11, 12
Time point:
other: Mean score after 24 ,48 and 72 hours
Score:
ca. 0.66
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: shaved skin
Irritation parameter:
edema score
Basis:
animal: 14, 16
Time point:
other: mean score after 24, 48 and 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: 13
Time point:
other: mean score after 24, 48 and 72 hours
Score:
ca. 1.33
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: shaved skin
Irritation parameter:
edema score
Basis:
animal: 15
Time point:
other: Mean score after 24, 48 and 72 hours
Score:
ca. 2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: shaved skin
Irritant / corrosive response data:
The value assessed at 24 hours was used also for 48 hours in a protective manner because no observation was made at 48 hours after the beginning of test.

Any other information on results incl. tables

Slight erythema and very slight to moderate oedeme was seen in 2/6 and 6/6 rabbits respectively, 24 hours after application of the compound. Very slight oedema was still present on 1/6 abraded sites at 72 hours.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified according to the CLP Regulation (EC n. 1272/2008)
Conclusions:
The substance is not irritating for skin rabbit.
Executive summary:

The substance has been tested for skin irritation according to the method "Hazardous Substances Regulations" under the U.S. federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965). During the test 5 male and 1 female rabbits are tested with 10 g of test item on shaved and abraded skin after 24 hours of patch treatment. Under the conditions of the present experiment the substance was considered to be not irritant for rabbit skin.