7-amino-4-hydroxynaphthalene-2-sulphonic acid

Endpoint summary

Description of key information

Skin Irritation:

/No skin irritation was observed after 7 days. Hence the test chemical can be considered as non-irritant to rabbits’ skin.

Eye Irritation:

No eye irritation was observed after 7 days. Hence the test chemical was considered as non-irritant to rabbit eyes.

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:

data from handbook or collection of data

Justification for type of information:

Data is from peer reviewed journal and safety asessment report

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

Skin irritation test was performed on to the inner surface of ears to assess the skin irritation potential of the test substance in two New Zealand White albino rabbits.

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Weight at study initiation: 3 – 4kg

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

24 hours

Observation period:

7 days

Number of animals:

2 (1/sex)

Details on study design:

TEST SITE
Area of exposure: inner surface of ears
% coverage: Not mentioned
Type of wrap if used: under an adhesive
dressing
REMOVAL OF TEST SUBSTANCE
Washing (if done): the test substance was washed off with water and soap/vegetable oil.
Time after start of exposure: after the exposure period

SCORING SYSTEM: Not mentioned

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

7 d

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No Irritation observed

Interpretation of results:

other: Not irritating

Conclusions:

In a skin irritation study, approx. 500 mg of test chemical was applied to the inner surface of the ears of 2 rabbits. No skin irritation was observed after 7 days. Hence the test chemical can be considered as non-irritant to rabbit skin.

Executive summary:

The skin irritation test was performed in two New Zealand White rabbits (male and female) to assess the skin irritation potency of test chemical for the observation period of 7 days.

 

In this skin irritation study, approx. 500 mg was applied to the inner surface of the ears of 2 rabbits. The test chemical was applied under an adhesive dressing for 24 hours.

 

At the end of the exposure period, the test substance was washed off with water and soap/vegetable oil. The observation period was 7 days.

 

No skin irritation was observed after 7 days. Hence the test chemical can be considered as non-irritant to rabbits’ skin.

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:

data from handbook or collection of data

Justification for type of information:

data from peer reviewed journal

Qualifier:

equivalent or similar to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

To assess the eye irritation potential of the test chemical in rabbits

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

50 mg

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

7 d

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No Irritation was observed

Interpretation of results:

other: not irritating

Conclusions:

In an eye irritation study, approx. 50mg of test chemical was instilled into the eyes of the rabbits. No eye irritation was observed after 7 days. Hence the test chemical was considered as non-irritant to rabbit eyes.

Executive summary:

An eye irritation test was conducted in rabbits for test chemical to assess the eye irritation potential.

 

In this study, 50 mg of test chemical was instilled into the conjunctival sac of 2 animals and animals were observed for 7 days.

 

No eye irritation was observed after 7 days. Hence the test chemical was considered as non-irritant to rabbit eyes.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin Irritation

Various studies have been reviewed to determine the degree of skin irritation caused by the test chemical in living organisms. These include in vivo experimental studies performed on rabbits for the test chemical. The results are summarized below:

The skin irritation test was performed in two New Zealand White rabbits (male and female) to assess the skin irritation potency of test chemical for the observation period of 7 days.

In this skin irritation study, approx. 500 mg was applied to the inner surface of the ears of 2 rabbits. The test chemical was applied under an adhesive dressing for 24 hours.

At the end of the exposure period, the test substance was washed off with water and soap/vegetable oil. The observation period was 7 days.

No skin irritation was observed after 7 days. Hence the test chemical can be considered as non-irritant to rabbits’ skin.

This is supported by the results of another study conducted in rabbits to assess the skin irritation potential of the test chemical. When the test chemical was applied on skin rabbits, no known signs of skin irritation were observed. Therefore the test chemical was considered to be not irritating to the skin of treated rabbits under the test condition.

These results are further supported by the acute dermal irritation study of test chemical 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.

Based on the results of the available studies, it can be considered that the test chemical certainly lacks the potential to cause irritation to skin. Hence, the test chemical can be considered to be not irritating to skin. Comparing the above annotations with the criteria of CLP Regulation, the test chemical can be classified under the category “Not Classified”.

Eye Irritation

Various studies have been reviewed to determine the level of ocular damage/irritation caused by the test chemical in living organisms. These include in vivo experimental studies performed on rabbits for the test chemical. The results are summarized below:

An eye irritation test was conducted in rabbits for test chemical to assess the eye irritation potential.

In this study, 50 mg of test chemical was instilled into the conjunctival sac of 2 animals and animals were observed for 7 days.

No eye irritation was observed after 7 days. Hence the test chemical was considered as non-irritant to rabbit eyes.

This is supported by the results of Draize test conducted on rabbits to determine the eye irritation potential of the test chemical.

500 mg of the test chemical was instilled for 24 hours to the eye of rabbit.

Only mild irritation was observed in treated rabbit but the potential of causing eye irritation was not sufficient to classify the chemical as an eye irritant. Therefore the test chemical was considered to be not irritating to the rabbit’s eye.

The above results are further supported by another ocular irritation study 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.

Based on the results of the available studies, it can be considered that the test chemical certainly lacks the potential to cause irritation to eyes. Hence, the test chemical can be considered to be not irritating to eyes. Comparing the above annotations with the criteria of CLP Regulation, the test chemical can be classified under the category “Not Classified”.

Justification for classification or non-classification

Available studies indicate a very strong possibility that the test chemical lacks the potential to cause irritation to skin and eyes. Therefore, the test chemical can be considered to be not irritating to eyes, skin.

Comparing the above annotations with the criteria of CLP Regulation, the test chemical can be classified under the category “Not Classified”.