Hexylamine

Endpoint summary

Description of key information

Skin Irritation:

In vivo study does not need to be conducted because the substance is a strong base. The pH of chemical was determined to be 12.9 which indicates the substance is highly basic and this study need not to be conducted for test chemical and considered as waiver. According to in vitro study, it was concluded that test chemical was considered to be irritant to human skin.

Eye Irritation:

In vivo study does not need to be conducted because the substance is a strong base. The pH of chemical was determined to be 12.9 which indicates the substance is highly basic and this study need not to be conducted for test chemical and considered as waiver. According to in vitro study, it was concluded that test chemical was considered to be irritant to human eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is a strong acid (pH ≤ 2.0) or base (pH ≥ 11.5) and the available information indicates that it should be classified as skin corrosion (Category 1, 1A, 1B or 1C)

Justification for type of information:

Based on information in Column II of annex VII of REACH regulation, study does not need to be conducted because the substance is a strong base. The pH of chemical was determined to be 12.9 which indicates the substance is highly basic and this study need not to be conducted for test chemical and considered as waiver.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is a strong acid (pH <= 2.0) or base (pH => 11.5) and the available information indicates that it should be classified as serious eye damage (Category 1)

Justification for type of information:

Based on information in Column II of annex VII of REACH regulation, study does not need to be conducted because the substance is a strong base. The pH of chemical was determined to be 12.9 which indicates the substance is highly basic and this study need not to be conducted for test chemical and considered as waiver.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation:

In different studies, the test chemical has been investigated for potential for dermal irritation to a greater or lesser extent. The studies are based on in- vitro and in-vivo experimental conducted in human and rabbits which have been summarized as below:

 

The in vivo study need not be conducted because the substance is a strong base (pH: 12.9). The experimental pH of test chemical was 12.9. Hence this endpoint was considered for waiver.

 

The dermal irritation potential of test article was determined according to the OECD 439 test guideline for this study. The MatTek EpiDerm™ model was used to assess the potential dermal irritation of the test article by determining the viability of the tissues following exposure to the test article via MTT. Tissues were exposed to the test article and controls for ~one hour, followed by a 42 hour post-exposure recovery period. The viability of each tissue was determined by MTT assay. The MTT data show the assay quality controls were met and passed the acceptance of criteria.

The Mean % tissue viability compared to negative control (n=3) of the test substance was determined to be 2.0 %.

Hence, under the current experimental test conditions it was concluded that test substance was considered to be irritating to human skin.

All these studies lead to a conclusion that Test chemical is indeed corrosive to skin. Hence, comparing the above annotations with the criteria of CLP regulation, Test chemical can be classified under the category “category 1 -corrosive”.

 

Eye irritation:

The In vivo study does not need to be conducted because the substance is a strong base. The pH of chemical was determined to be 12.9 which indicates the substance is highly basic and this study need not to be conducted for test chemical and considered as waiver.

 

The ocular irritation potential of test article was determined according to the OECD 492 test guideline for this study. The MatTek EpiOcular™ model was used to assess the potential ocular irritation of the test articles by determining the viability of the tissues following exposure to the test article via MTT. Tissues were exposed to liquid test articles and controls for ~30 minutes, followed by a ~12 minute post-soak and approximately 2 hour recovery after the post-soak. The viability of each tissue was determined by MTT assay.

The MTT data show the assay quality controls were met, passing the acceptance criteria.

The mean % tissue viability of test substance was determined to be 2.3 %. Hence, under the experimental test conditions it was concluded that test substance was considered to be irritating to the human eyes.

All these studies lead to a conclusion that Test chemical is indeed corrosive to eye. Hence, comparing the above annotations with the criteria of CLP regulation, Test chemical can be classified under the category “category 1 -corrosive”.

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008) and based on the high pH of test chemical (pH= 12.9), the classification Skin Corrosive 1B and Eye Damage 1 is proposed for test chemical.