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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Step 1: Date of start of the experimental period: 25 May 2004 / Date of end of the experimental period: 28 May 2004 Step 2: Date of start of the experimental period: 1 Jun. 2004 / Date of end of the experimental period: 4 Jun. 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
On 20 April 2004, one sample of CAN 5, batch No. February 2004, was received. Immediately upon receipt, CAN 5 was registered, then stored at ambient temperature and protected from light in accordance with the Sponsor's instructions.

Appearance: White powder.
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:

Choice of species: The rabbit was chosen because of its acceptance as a predictor of irritanti corrosive effects of chemicals in man and the recognition by regulatory authorities that this species is suitable far skin irritation studies.

Sex: Female

Origin: Animals came from the CEGAV specialised breeding establishment (Les Hautes Noes, Saint Mars d1Egrenne, 61350 Passais la Conception, France).

Date of delivery: 19 May 2004.

Identification: Animals were individually identified by an ear clip.

Body weight: Between 2.4 kg and 2.5 kg at the start of the experiment.

Acclimatisation: Far at least 5 days before the treatment, in the area w bere the experiment took piace.

Housing: Animals were housed individually in cages of standard size. Excreta were removed by unrolling plasticised brown paper, previously placed under cages. These cages were placed in an airconditioned (17- 21 "C) animal house kept at between 45 % and 65 % relative humidity in which non-recycled filtered air was changed approximately ten times per hour. The artificial day/night cycle was 12 hours light and 12 hours darkness with light on at 7.30 a.m.

Feeding: SDS/DIETEX STANRAB (P) SQC feed was distributed daily at fixed times. The criteria far acceptable levels of contaminants in the feed supply was within the limits of the analytical specifications established by the diet manufacturer.

Drinking water: Drinking water was available ad libitum in polycarbonate feeder bottles with a stainless steel nipple. A specimen of water is obtained every 6 months and sent to the Laboratoire Départemental d' Analyse du Cher- 216 rue Louis Mallet, 18014 Bourges Cedex, France- far analysis.

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
yes
Amount / concentration applied:
As required by the guideline, 0.5 g of CAN 5 was applied.

0.5 g of CAN 5 was applied to the skin of the right fiank region. For this purpose, approximately 24 hours before the test, the treatment region of each rabbit was carefully clipped free of fur over an area of at least 14 cm x 5 cm. Care was taken to avoid abrading the skin. Only animals with healthy intact skin by gross observation was used far the study. A percentage of New Zealand albino rabbits have dense patches of hair, which are more prominent at certa in times of the year. Such areas were not used as treatment sites.The test substance was applied at the selected area on the right flank of each animal. The test substance was placed on a ganze square of approximately 6 cm2. Each application was sufficiently moistened with 0.5 mL of sterile water in order to allow good contact between the test substance and the skin. The side of the ganze square covered with the test substance was applied to the skin. This ganze square was protected by a pad consisting of a semi-occlusi ve micro-porous and non-allergenic dressing and held in piace with a supple and aerated fastening system consisting of elastic, adhesive, hypoallergenic tape. The animals were fitted with this pad far the duration of the exposure period.
Duration of treatment / exposure:
CAN 5 was applied once only, at a duration of exposure of 4 hours.
Observation period:
One hour, 24 hours, 48 hours and 72 hours approximately after remaval of the dressing, any skin lesion, which may bave developed on the right flank of each animal, was evaluated.
Number of animals:
Three animals were required for the complete test.
Details on study design:
TEST SITE
- Area of exposure: the test substance was placed on a ganze square of approximately 6 cm2
- coverage: area of at least 14 cm x 5 cm.
- Type of wrap if used: the test substance was placed on a ganze square of approximately 6 cm2. Each application was sufficiently moistened with 0.5 mL of sterile water in order to allow good contact between the test substance and the skin. The side of the ganze square covered with the test substance was applied to the skin. This ganze square was protected by a pad consisting of a semi-occlusi ve micro-porous and non-allergenic dressing and held in piace with a supple and aerated fastening system consisting of elastic, adhesive, hypoallergenic tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, the dressing was removed and no residual test substance was noted. The day of application was taken as D1 of the study.
- Time after start of exposure: CAN 5 was applied once only, at a duration of exposure of 4 hours.

OBSERVATION TIME POINTS
One hour, 24 hours, 48 hours and 72 hours approximately after remava! of the dressing, any skin lesion, which may bave developed on the right flank of each anima!, was evaluated.

SCORING SYSTEM:
- Method of calculation: Lesions were graded using the following scoring system in accordance with OECD Guideline No. 404 (See on materials and methods tables).
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1 h
Score:
1
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
1
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 1 h
Score:
1
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation

The application of the test substance did not induce coloration of the application site and did not interfere with grading of any skin lesion. Any cutaneous lesion was evaluated approximately one hour, 24, 48 and 72 hours after removal of the dressing. Mean indices were calculated from results obtained from each rabbit at times 24, 48 and 72 hours.

Results obtained (Mean index (Mi)) were as follows:

Treatment

Animal number

Erythema

Oedema

CAN 5

20040354

20040355

20040356

1

0.33

0

0

0

0

Interpretation of results:
GHS criteria not met
Conclusions:
Under the experimental conditions adopted, CAN 5 (batch February 2004) was found to be non irritant for the skin of the Rabbit.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Under the experimental conditions adopted in the acute skin irritation study in the rabbit (OECD 404), the substance was found to be non irritant for the skin. Available data are regarded as conclusive in order to exclude the classification of the substance for this hazard