Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

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

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
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

Any other information on results incl. tables

  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

Applicant's summary and conclusion

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.