Registration Dossier

Administrative data

Description of key information

Skin Irritation

Since the test chemical did not induce any skin reaction, it was considered as not irritating to the intact or scarified skin New Zealand White rabbits after exposure of 4 hours.

Eye Irritation

Slight hyperemia was observed in treated rabbit but the effects were not persisted up to 72 hours, hence the test chemical was considered to be not irritating to the eyes of treated New Zealand White rabbit.

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:
October - December 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Data is from experimental study
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
The skin irritation study of test chemical was conducted on single New Zealand White rabbits to assess its skin irritation potential.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
not specified
Type of coverage:
not specified
Preparation of test site:
other: scarified skin
Vehicle:
water
Controls:
not required
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 hours
Observation period:
24, 48, 72 hours
Number of animals:
1
Details on study design:
- Parameters analysed / observed: hyperemia, edema on intact or scarified skin
Irritation parameter:
other: observation of intact skin
Basis:
animal #1
Time point:
24 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
other: observation of scarified skin
Basis:
animal #1
Time point:
24 h
Score:
> 1 - < 2
Remarks on result:
other: slight congestion, slight edema
Irritation parameter:
other: observation of scarified skin
Basis:
animal #1
Time point:
other: 48/72 h
Score:
> 1 - < 2
Remarks on result:
other: very weak edema
Interpretation of results:
other: Not irritating
Conclusions:
The test chemical was considered to be not irritating to the intact or scarified skin New Zealand White rabbits after exposure of 4 hours.
Executive summary:

The acute dermal irritation study of test chemical was conducted on New Zealand White rabbit to assess its skin irritation potential.

500mg of chemical was applied for 4 hours and skin was analyzed hyperemia, edema on intact or scarified skin at 24, 48, 72 hours after exposure.

Since the test chemical did not induce any skin reaction, it was considered as not irritating to the intact or scarified skin New Zealand White rabbits after exposure of 4 hours.

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:
October - December 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Data is from experimental study report
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
An ocular irritation study was conducted on New Zealand White rabbit to assess its eye irritation potential.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.1 g (100mg)of sample
Duration of treatment / exposure:
not specified
Observation period (in vivo):
24 and 72 h
Number of animals or in vitro replicates:
1 rabbit
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
24 h
Score:
ca. 1
Reversibility:
fully reversible within: max. 48 h
Remarks on result:
other: very weak hyperemia
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
72 h
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No eye irritation was observed in treated rabbit.
Interpretation of results:
other: non-irritating
Conclusions:
Slight hyperemia was observed in treated rabbit but the effects were not persisted up to 72 hours, hence the test chemical was considered to be not irritating to the eyes of treated New Zealand White rabbit.
Executive summary:

An ocular irritation study was conducted on New Zealand White rabbit to assess its eye irritation potential.

Approx 100mg of undiluted test chemical was instilled into the eye of rabbit and observed for damage of cornea and mucosa (hyperemia, edema) at 24, 48 and 72 hours.

Slight hyperemia was observed in treated rabbit but the effects were not persisted up to 72 hours, hence the test chemical was considered to be not irritating to the eyes of treated New Zealand White rabbit.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation

In different studies,the test chemicalhas been investigated for its potential to cause dermal irritation to a greater or lesser extent. The studies are based on in vivo experiments in rabbits along with estimated data for the test chemical. The results are summarized as follows:

The acute dermal irritation study of test chemical was conducted on New Zealand White rabbit to assess its skin irritation potential.

500mg of chemical was applied for 4 hours and skin was analyzed hyperemia, edema on intact or scarified skin at 24, 48, 72 hours after exposure.

Since the test chemical did not induce any skin reaction, it was considered as not irritating to the intact or scarified skin New Zealand White rabbits after exposure of 4 hours.

This is supported by the results of another skin irritation study performed in 2 New Zealand White rabbits to assess the skin irritation potency of test chemical.

 In this study, approx. 500 mg of test chemical (dry and ground, made into a paste with water) was applied to the inner surface of the ears of rabbits under an adhesive dressing for 24 hours. At the end of the exposure period, the test substance was washed off with water and soap and observations were made for 7 days.

 Since no known skin irritating effects were observed during the 7 days observation period, the test chemical was considered as not irritating to rabbits skin.

Skin irritation effects were also estimated by four different models i.e, Battery, Leadscope, SciQSAR and CASE Ultra used within Danish QSAR database for the test chemical. Based on estimation, No severe skin irritation effects were known when the test chemical was exposed to rabbit skin. Hence, the test chemical was estimated to be not irritating to skin.

Available studies fortest chemicalindicate that it lacks the potential to cause any irritation to the eyes. Hence, it can be considered to be not irritating to skin. Comparing the above annotations with the criteria of the CLP regulation, the test chemical can be classified under the category “Not Classified”.

Eye irritation

In different studies,the test chemicalhas been investigated for its potential to cause ocular irritation to a greater or lesser extent. The studies are based on in vivo experiments in rabbits or the test chemical. The results are summarized as follows:

An ocular irritation study was conducted on New Zealand White rabbit to assess its eye irritation potential.

Approx 100mg of undiluted test chemical was instilled into the eye of rabbit and observed for damage of cornea and mucosa (hyperemia, edema) at 24, 48 and 72 hours.

Slight hyperemia was observed in treated rabbit but the effects were not persisted up to 72 hours, hence the test chemical was considered to be not irritating to the eyes of treated New Zealand White rabbit.

This is supported by the results of an eye irritation study performed to determine the eye irritation potential of the test chemical in rabbits.About 50 mg (the test chemical was dry and ground, made into paste with water) was instilled into the eyes of 2 New Zealand White rabbits. The rabbits were observed for signs of irritation till 7 days.

Slight reddening was seen in 1 rabbits after 1 hour after application which got completely cleared up by 3 days.

Since the effects were fully reversible, the test chemical was considered to be not irritating to rabbit eyes.

The above results are further supported by the study conducted in rabbits to determine the presence or absence of adverse eye effects caused by the test chemical.

The test chemical was applied into the eyes of each rabbit and observed for effects. The test chemical caused slight reddening for a short time in 2 animals.

As the observed effects were not persisted, the test chemical was considered to be not irritating to the rabbits´ eye.

Available studies fortest chemicalindicate that it lacks the potential to cause any irritation to the eyes. Hence, it can be considered to be not irritating to eyes. Comparing the above annotations with the criteria of the CLP regulation, the test chemical can be classified under the category “Not Classified”.

 

Justification for classification or non-classification

Available studies for the test chemical indicate that it lacks the potential to cause irritation to eyes and skin. Therefore the test chemical can be considered to be not irritating to skin and eyes. Hence, it can be classified under the category "NOT CLASSIFIED" under CLP criteria.