Merbromin

Endpoint summary

Description of key information

Skin Irritation

Based on the available results of the experimental studies and applying the weight of evidence approach, the test chemical can be estimated to lack the potential to cause irritation to skin. Hence, it can be considered to be not irritating to skin and classified under the category “Not Classified” as per CLP Regulation.

Eye Irritation

The ocular irritation potential of the test chemical was in rabbits. 2% solution of the test chemical was instilled into the eyes of 1 rabbit and observed for effects(duration of exposure, observation period not mentioned).

Instillation of the 2% solution of the test chemical in the conjunctival sac of the animal did not cause any irritation to rabbit eyes. Hence, the test chemical can be considered to be not irritating to eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Remarks:

Weight of evidence approach based on various test chemicals

Justification for type of information:

Weight of evidence approach based on various test chemicals

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: Weight of evidence approach based on various test chemicals

Principles of method if other than guideline:

Weight of evidence approach based on various test chemicals. The study 2,3 are referred as study 1,2

GLP compliance:

not specified

Species:

rat

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

1. Dose Rnage Finding Study - 200 mg/kg, 1000 mg/kg and 2000 mg/kg; Main study - 2000 mg/kg
2. 2000 mg/kg

Duration of treatment / exposure:

1. 24 hours
2. 24 hours

Observation period:

1. 14 days
2. 14 days

Number of animals:

1. 5 female rats
2. 10 rats- 5/sex

Irritation parameter:

erythema score

Basis:

mean

Time point:

14 d

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

mean

Time point:

14 d

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No signs of irritation observed

Interpretation of results:

other: not irritating

Conclusions:

Based on the available results of the experimental studies and applying the weight of evidence approach, the test chemical can be estimated to lack the potential to cause irritation to skin. Hence, it can be considered to be not irritating to skin and classified under the cateogory “Not Classified” as per CLP Regulation.

Executive summary:

Various studies have been investigated to determine the dermal irritation of the test chemical in living organisms. The results include in vivo experimental studies on rats for the test chemicals. The results are summarized as follows:

A study designed and conducted to determine the dermal reaction profile of the test chemical in Wistar rats. The study was performed as per OECD Guidelines 402 and complying to the GLP procedures. Wistar rats were tested with 200 mg/kg, 1000 mg/kg and 2000 mg/kg with 1 female for the dose range finding study, followed by additional 2 females for main study at the dose of 2000 mg/kg body weight. Based on the individual body weight, the test item at the dose of 200 mg/kg, 1000 mg/kg and 2000 mg/kg body weight was weighed on an aluminium foil and made into a paste by adding sufficient volume of the Milli-Q water and completely transferred on to the cotton gauze (size: Females: 8 x 5 cm of 6 ply) and applied directly (semi-occlusive) to the clipped skin of the rat to cover about 10% of body surface of the rat. It was secured in position by adhesive tape wound around the torso. The

test item contact period with the skin was for 24 hours. After the 24 hours contact period, the dressing was removed and the applied area was washed with deionized water and wiped dry using clean towels.

All the rats were observed for clinical signs of toxicity and mortality for 14 days post application. In addition, the treatment site was observed at 24, 48 and 72 hours after removal of test item using the Draize criteria.

There were no clinical signs of toxicity and mortality. There were no skin reactions at the site of application at 24, 48 and 72 hours after test patch removal (as per Draize method). The mean erythema and edema scores were 0.0 at all observation times. Hence, it was concluded that the test chemical was "Not Irritating" to the skin of Wistar rats under the experimental conditions tested and classified as “Category-Not Classified” as per CLP Classification.

This is supported by a similar study designed and conducted to determine the dermal reaction profile of the test chemical in Sprague Dawley rats. The study was performed as per OECD Guidelines 402 and complying to the GLP procedures.

The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days.   

Animals exhibited normal body weight gain through the study period of 14 days.

Gross pathological examination did not reveal any abnormalities attributable to the treatment. The overall irritation score of the substance was determined to be 0 and no erythema and edema (skin irritation) were observed at the end of 14 days after patch removal. Hence, it was concluded that the test chemical was not-Irritating to the skin of rats under the experimental conditions tested .Thus it can be concluded that the test chemical can be classified under the category "Not Classified" as per CLP regulation.

Based on the available results of the experimental studies and applying the weight of evidence approach, the test chemical can be estimated to lack the potential to cause irritation to skin. Hence, it can be considered to be not irritating to skin and classified under the cateogory “Not Classified” as per CLP Regulation.

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:

weight of evidence

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 journals

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

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

GLP compliance:

not specified

Species:

rabbit

Strain:

not specified

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

2% solution of the test chemical

Duration of treatment / exposure:

no data available

Observation period (in vivo):

no data available

Duration of post- treatment incubation (in vitro):

no data available

Number of animals or in vitro replicates:

1

Details on study design:

TEST SITE
- Area of exposure: conjunctivae

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: no data available

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Instillation of the 2% solution of the test chemical in the conjunctival sac of the animal did not cause any irritation to rabbit eyes.

Interpretation of results:

other: not irritating

Conclusions:

Instillation of the 2% solution of the test chemical in the conjunctival sac of the animal did not cause any irritation to rabbit eyes. Hence, the test chemical can be considered to be not irritating to eyes.

Executive summary:

The ocular irritation potential of the test chemical was in rabbits. 2% solution of the test chemical was instilled into the eyes of 1 rabbit and observed for effects(duration of exposure, observation period not mentioned).

Instillation of the 2% solution of the test chemical in the conjunctival sac of the animal did not cause any irritation to rabbit eyes. Hence, the test chemical can be considered to be not irritating to 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 investigated to determine the dermal irritation of the test chemical in living organisms. The results include in vivo experimental studies on rats for the test chemicals. The results are summarized as follows:

A study designed and conducted to determine the dermal reaction profile of the test chemical in Wistar rats. The study was performed as per OECD Guidelines 402 and complying to the GLP procedures. Wistar rats were tested with 200 mg/kg, 1000 mg/kg and 2000 mg/kg with 1 female for the dose range finding study, followed by additional 2 females for main study at the dose of 2000 mg/kg body weight. Based on the individual body weight, the test item at the dose of 200 mg/kg, 1000 mg/kg and 2000 mg/kg body weight was weighed on an aluminium foil and made into a paste by adding sufficient volume of the Milli-Q water and completely transferred on to the cotton gauze (size: Females: 8 x 5 cm of 6 ply) and applied directly (semi-occlusive) to the clipped skin of the rat to cover about 10% of body surface of the rat. It was secured in position by adhesive tape wound around the torso. The test item contact period with the skin was for 24 hours. After the 24 hours contact period, the dressing was removed and the applied area was washed with deionized water and wiped dry using clean towels.

All the rats were observed for clinical signs of toxicity and mortality for 14 days post application. In addition, the treatment site was observed at 24, 48 and 72 hours after removal of test item using the Draize criteria.

There were no clinical signs of toxicity and mortality. There were no skin reactions at the site of application at 24, 48 and 72 hours after test patch removal (as per Draize method). The mean erythema and edema scores were 0.0 at all observation times. Hence, it was concluded that the test chemical was "Not Irritating" to the skin of Wistar rats under the experimental conditions tested and classified as “Category-Not Classified” as per CLP Classification.

This is supported by a similar study designed and conducted to determine the dermal reaction profile of the test chemical in Sprague Dawley rats. The study was performed as per OECD Guidelines 402 and complying to the GLP procedures.

The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days.   

Animals exhibited normal body weight gain through the study period of 14 days.

Gross pathological examination did not reveal any abnormalities attributable to the treatment. The overall irritation score of the substance was determined to be 0 and no erythema and edema (skin irritation) were observed at the end of 14 days after patch removal. Hence, it was concluded that the test chemical was not-Irritating to the skin of rats under the experimental conditions tested .Thus it can be concluded that the test chemical can be classified under the category "Not Classified" as per CLP regulation.

Based on the available results of the experimental studies and applying the weight of evidence approach, the test chemical can be estimated to lack the potential to cause irritation to skin. Hence, it can be considered to be not irritating to skin and classified under the category “Not Classified” as per CLP Regulation.

Eye Irritation

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

The ocular irritation potential of the test chemical was in rabbits. 2% solution of the test chemical was instilled into the eyes of 1 rabbit and observed for effects(duration of exposure, observation period not mentioned).

Instillation of the 2% solution of the test chemical in the conjunctival sac of the animal did not cause any irritation to rabbit eyes. Hence, the test chemical can be considered to be not irritating to eyes.

This is supported by the results of the experimental studies performed on humans and rabbits. Instillation of the test chemical failed to cause any irritation to eyes of humans and rabbits.

These results are supported by the a study performed to evaluate the Primary eye irritation potential for the test chemical.

0.2mL of 10% aqueous solution was applied in the conjunctival sac of one eye of a group of at least 6 albino rabbits. The application was repeated twice daily, 5 days per week for 4 weeks. One hour after each application the eyes were examined for evidence of staining and irritation was scored according to Draize. Three days after the last application, two animals of each group were killed; upper lids were taken for microscopic examination. Eyeballs and posterior parts were examined grossly for evidence of staining or other abnormalities.

The test chemical caused intense colouring of the iris and moderate conjunctival irritation. Staining lasted from 2 to 7 days. Thus, the test chemical can be regarded as non-irritating to the rabbit eyes.

Based on the available results of the experimental studies and applying the weight of evidence approach, the test chemical can be considered to lack the potential to cause irritation to skin. Hence, it can be classified under the category “Not Classified” as per CLP Regulation.

Justification for classification or non-classification

Based on the available results of the experimental studies and applying the weight of evidence approach, the test chemical can be estimated to lack the potential to cause irritation to skin and eyes. Hence, it can be considered to be not irritating to skin and eyes.It can be classified under the cateogory “Not Classified” as per CLP Regulation.