Registration Dossier

Administrative data

Description of key information

Skin irritation: Only one rabbit exhibited very slight erythema at the 24 hour observation. There was no other irritation effect noted in any other rabbits at the 24 hour observation and all rabbits appeared normal at the 72 hour observation. All observed effects were reversed by the 72 -hour observation.
Eye irritation: No effects were observed in any animal at any observation period.

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:
7/12/82 to 7/23/82
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP conducted according to guideline 16 CFR Section 1500.41 of the Federal Hazardous Substances Act Regulations
Qualifier:
according to
Guideline:
other: 16 CFR Section 1500.41
Principles of method if other than guideline:
The method employed in the testing, evaluations and the soring was similar to that described in Section 1500.41-Federal Hazardous Substances Act Regulations -16 CFR.
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
The animals were housed and maintained in compliance with the Animal Welfare Act (Pub. L-94-279) 9 CFR Part 3Temperatuire - 70°F (+- 2°F)Relative Humidity 45% (+-5%)Light: 12 hour light/dark cycleDiet - Wayne 15 % Rabbit Ration and tap water were provided ad libitum.Caging: Stainless steel with elevated wire mesh flooring. 1 rabbit/cageBedding: Deotized Animal Cage Board (DACB). Sheperd Products Company. Kalamazoo, Michigan 49005
Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
other: One site of the animal's treated on abraded zone, and the other side remained intact
Amount / concentration applied:
A 0.5 ml portion of material was applied to an abraded and an intact site on the same rabbit.
Duration of treatment / exposure:
The wrapping was removed at the end of the 24 hour period.
Observation period:
Treated areas were examined directly after the removal and readings were also made 72 hours after.
Number of animals:
A group of 6 rabbits were clipped
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0.083
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
See Table

  Erythema and eschar formation
   Reading (hours)                 Rabbit number  Average
     1  2  3  4  5  6  
 Intact Skin  24  1  0  0  0  0  0.17
 Intact Skin  72  0  0  0  0  0  0  0
 Abraded Skin  24  0  1  0  0  0  0  0.17
 Abraded Skin  72  0  0  0  0  0  0  0
                    Subtotal  0.34

  Edema Formation
   Reading (hours)                 Rabbit number  Average
     1  2  3  4  5  6  
 Intact Skin  24  0  0  0  0  0  0  0
 Intact Skin  72  0  0  0  0  0  0  0
 Abraded Skin  24  0  0  0  0  0  0  0
 Abraded Skin  72  0  0  0  0  0  0  0
                    Subtotal  0
     Total  0.34

Primary irritation Score: 0.34/4=0.09

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not a skin irritant in rabbits.In accordance with EU CLP Regulation (EC) No. 1272/2008 classification of this substance is not required for dermal irritation.
Executive summary:

Test Guidance

Skin irritation study performed by a similar method to 16 CFR 1500.41 of the Federal Hazardous Substances Act Regulations.

Method and Material

Six New Zealand White rabbits were clipped and then one side of the back was abraded to penetrate the stratum corneum with the other side kept intact. A 0.5 mL portion of the test material was applied to an abraded and an intact skin site of the same rabbit. A gauze patch was placed over each application site and an impervious material was wrapped around the trunk of the animal to hold the patches. The wrapping was removed after 24 hours. Treated areas were examined for erythema and edema using the Draize method of scoring at 24 and 72 hours.

Results

Only one rabbit exhibited very slight erythema at the 24 hour observation. There was no other irritation effect noted in any other rabbits at the 24 hour observation and all rabbits appeared normal at the 72 hour observation. All observed effects were reversed by the 72 -hour observation.

Conclusion

In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for skin irritation.

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
Study period:
7/12/82 to 9/16/82
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP conducted according to guideline 16 CFR Section 1500.42 of the Federal Hazardous Substances Act Regulations
Qualifier:
according to
Guideline:
other: 16 CFR- Federal Hazardous Substances Act Regulations- Section 1500.42
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
The animals were housed and maintained in compliance with the Animal Welfare Act (Pub. L-94-279) 9 CFR Part 3Temperatuire - 70°F (± 2°F)Relative Humidity 45% (± 5%)Light: 12 hour light/dark cycleDiet - Wayne 15 % Rabbit Ration and tap water were provided ad libitum.Caging: Stainless steel with elevated wire mesh flooring. 1 rabbit/cageBedding: Deotized Animal Cage Board (DACB). Sheperd Products Company. Kalamazoo, Michigan 49005
Vehicle:
unchanged (no vehicle)
Controls:
other: Test material instilled in the right eye while the left eye served as control
Amount / concentration applied:
0.1 ml of the experimental material
Duration of treatment / exposure:
Material was not washed from the eyes
Observation period (in vivo):
The treated eyes were examined at one, two, three, four and seven days following instillation of the test material into the eyes
Number of animals or in vitro replicates:
Six healthy young adult new zealand White rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE- Washing (if done): NoSCORING SYSTEM: Draize method
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hour
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hour
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hour
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hour
Score:
0
Max. score:
4
Irritant / corrosive response data:
No irritant effects were noted at any timepoint in the study.

All the individual daily scores for all the rabbits are 0. That means:

No Opacity of Cornea for all the animals, for all records.

Normal irises for all the animals, for all records.

Neither chemosis nor redness of the conjuntivaes for all the animals, for all records.

Interpretation of results:
GHS criteria not met
Conclusions:
There were no irritant effects in the eye of rabbits.In accordance with EU CLP Regulation No. 1272/2008 classification of this substance is not required for eye irritation..
Executive summary:

Test Guidance

Eye irritation study performed by a similar method to 16 CFR 1500.42 of the Federal Hazardous Substances Act,

Method and Material

0.1 mL of the test material was instilled into the right eye of six young adult albino rabbits. The left eye served as the untreated control. The test material was not washed from the eye. Treated eyes were examined at 1, 2, 3, 4 and 7 days following treatment. Interpretation of results was made in accordance with the Draize scale.

Results

No effects were observed in any animal at any observation period.

Conclusion

In accordance with EU CLP Regulation No. 1272/2008 classification of this substance is not required for eye irritation.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Dermal

Test Guidance

Skin irritation study performed by a similar method to 16 CFR 1500.41 of the Federal Hazardous Substances Act Regulations.

Method and Material

Six New Zealand White rabbits were clipped and then one side of the back was abraded to penetrate the stratum corneum with the other side kept intact. A 0.5 mL portion of the test material was applied to an abraded and an intact skin site of the same rabbit. A gauze patch was placed over each application site and an impervious material was wrapped around the trunk of the animal to hold the patches. The wrapping was removed after 24 hours. Treated areas were examined for erythema and edema using the Draize method of scoring at 24 and 72 hours.

Results

Only one rabbit exhibited very slight erythema at the 24 hour observation. There was no other irritation effect noted in any other rabbits at the 24 hour observation and all rabbits appeared normal at the 72 hour observation. All observed effects were reversed by the 72 -hour observation.

Conclusion

In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for skin irritation.

Eye

Test Guidance

Eye irritation study performed by a similar method to 16 CFR 1500.42 of the Federal Hazardous Substances Act.

Method and Material

0.1 mL of the test material was instilled into the right eye of six young adult albino rabbits. The left eye served as the untreated control. The test material was not washed from the eye. Treated eyes were examined at 1, 2, 3, 4 and 7 days following treatment. Interpretation of results was made in accordance with the Draize scale.

Results

No effects were observed in any animal at any observation period.

Conclusion

In accordance with EU CLP Regulation No. 1272/2008 classification of this substance is not required for eye irritation.

Justification for classification or non-classification

In accordance with the CLP Regulation, No 1272/2008, a substance should be classified as a skin irritant if:

- Mean value of ≥ 2,3 - ≤ 4,0 for erythema/eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or

- Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or

- In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.

In the skin irritation study, only one rabbit exhibited very slight erythema at the 24 hour observation. There was no other irritation effect noted in any other rabbits at the 24 hour observation and all rabbits appeared normal at the 72 hour observation. All observed effects were reversed by the 72 -hour observation. As such, the test item does not meet the classification criteria.

In accordance with the CLP Regulation, No 1272/2008, a substance should be classified as a eye irritant if, for reversible effects:

if, when applied to the eye of an animal, a substance produces:

— at least in 2 of 3 tested animals, a positive response of:

— corneal opacity ≥ 1 and/or

— iritis ≥ 1, and/or

— conjunctival redness ≥ 2 and/or

— conjunctival oedema (chemosis) ≥ 2

— calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days.

In the eye irritation study, no effects were observed in any animal at any observation period. Therefore, the test item does not meet the classification criteria.