Registration Dossier

Administrative data

Description of key information

Valid in vivo studies in rabbits for skin irritation/corrosion and for eye irritation are available.

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
An amount of 0.5 g of the test substance was brought on the intact or abraded skin under a surgical patch measuring 1 x 1 inch. The patches were fixed to the application site by means of adhesive tape and the entire trunk of the rabbits was wrapped with an impervious material to maintain the test patches in position and to retard evaporation of volatile substances. Six rabbits are treated on the intact skin, the other six on the abraded skin. After an exposure period of 24 hours the patches and the material applied are removed and the resulting skin reactions were evaluated by the method of Draize.
GLP compliance:
no
Specific details on test material used for the study:
WTR 44 = Vulkacit P = CAS no. 14634-93-6
White powder
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Twelve healty adult New Zealand White albino rabbits were used for the test. Twenty four hours prior to applying the materials, the hair was removed from the backs of the animals with an electric clipper in such a way to avoid abrasions.
Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
12 animals
Details on study design:
After an exposure period of 24 hours the patches and the material applied were removed and the resulting skin reactions are evaluated by the method of Draize. A second reading was made 48 hours later (72 hours after application).
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritant / corrosive response data:
No signs of skin irritation could be detected in any of the test animals, either at the end of the 24-hour application period or 48 hours later.
Interpretation of results:
GHS criteria not met
Conclusions:
No signs of skin irritation could be detected in any of the test animals, either at the end of the 24-hour application period or 48 hours later.
Executive summary:

An amount of 0.5 g of the test substance was brought on the intact or abraded skin under a surgical patch measuring 1 x 1 inch. The patches were fixed to the application site by means of adhesive tape and the entire trunk of the rabbits was wrapped with an impervious matrial to maintain the test patches in position and to retard evaporation of volatile substances. Six rabbits are treated on the intact skin, the other six on the abraded skin. After an exposure period of 24 hours the patches and the material applied are removed and the resulting skin reactions were evaluated by the method of Draize. No signs of skin irritation could be detected in any of the test animals, either at the end of the 24-hour application period or 48 hours later.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Six New Zealand White albino rabbits are used for each test substance. The animals are caged individually and receive no hay or other extraneous material that might enter the eyes. 100 milligrams of the test substance, is allowed to fall on the everted lower lid of one eye of each rabbit; the upper and lower eye lid are then carefully closed and subsequently held together for at least one second before releasing, to prevent loss of material. The other eye, remaining untreated, serves as a control. The eyes are not washed following instillation and the animals are released immediately. The eyes are examined at 24, 48, 72 hours and 7 days after instillation of the test material.
GLP compliance:
no
Specific details on test material used for the study:
WTR 44 = Vulkacit P = CAS no. 14634-93-6
White powder
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Six New Zealand White albino rabbits are used for each test substance. The animals are caged individually and receive no hay or other extraneous material that might enter the eyes.
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 milligram
Duration of treatment / exposure:
7 days (the eyes are not washed following instillation).
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6 animals
Details on study design:
100 milligrams of the test substance, is allowed to fall on the everted lower lid of one eye of each rabbit; the upper and lower eye lid are then carefully closed and subsequently held together for at least one second before releasing, to prevent loss of material. The other eye, remaining untreated, serves as a control. The eyes are not washed following instillation and the animals are released immediately. The eyes are examined at 24, 48, 72 hours and 7 days after instillation of the test material.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0.11
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: score = 0 at any time point
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.39
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: after 7 days 2 rabbits had a score = 1
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Iris score was 0 (24,48, 72 hours). The cornea score was 0.11 (24, 48, 72 hours), the conjunctivae score was 1.39 (24,48, 72 hours) and the chemosis score was 0.66 (24, 48 and 72 hours). The cornea score and the chemosis score were fully reversible within 72 hours. the conjunctivae score was 1 after 7 days in 2 out of 6 animals.
Interpretation of results:
GHS criteria not met
Conclusions:
The iris score was 0 (24, 48, 72 hours). The cornea score was 0.11 (24, 48, 72 hours), the conjunctivae score was 1.39 (24, 48, 72 hours) and the chemosis score was 0.66 (24, 48 and 72 hours). The cornea score and the chemosis score were fully reversible within 72 hours. The conjunctivae score was 1 after 7 days in 2 out of 6 animals.
Executive summary:

Six New Zealand White albino rabbits are used for each test substance. The animals are caged individually and receive no hay or other extraneous material that might enter the eyes. 100 milligrams of the test substance, is allowed to fall on the everted lower lid of one eye of each rabbit; the upper and lower eye lid are then carefully closed and subsequently held together for at least one second before releasing, to prevent loss of material. The other eye, remaining untreated, serves as a control. The eyes are not washed following instillation and the animals are released immediately. The eyes are examined at 24, 48, 72 hours and 7 days after instillation of the test material.

The iris score was 0 (24, 48, 72 hours). The corne score was 0.11 (24, 48, 72 hours), the conjunctivae score was 1.39 (24, 48, 72 hours) and the chemosis score was 0.66 (24, 48 and 72 hours). The cornea score and the chemosis score were fully reversible within 72 hours. The conjunctivae score was 1 after 7 days in 2 out of 6 animals.

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

In the skin irritation/corrosion study no signs of skin irritation (score = 0) could be detected in any of the test animals, either at the end of the 24-hour application period or 48 hours later.

In the eye irritation study six New Zealand White albino rabbits are used. 100 milligrams of the test substance, is allowed to fall on the everted lower lid of one eye of each rabbit; the upper and lower eye lid are then carefully closed and subsequently held together for at least one second before releasing, to prevent loss of material. The other eye, remaining untreated, serves as a control. The eyes are not washed following instillation and the animals are released immediately. The eyes are examined at 24, 48, 72 hours and 7 days after instillation of the test material.

The iris score was 0 (24, 48, 72 hours). The cornea score was 0.11 (24, 48, 72 hours), the conjunctivae score was 1.39 (24, 48, 72 hours) and the chemosis score was 0.66 (24, 48 and 72 hours). The cornea score and the chemosis score were fully reversible within 72 hours. The conjunctivae score was 1 after 7 days in 2 out of 6 animals.

According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.