Hexamethylenediamine

Endpoint summary

Description of key information

- Skin irritation: Corrosive (OECD 435, Kr: 1)
- Eye irritation: highly irritating, induced irreversible effects ( 92/69/EEC, B.5, Kr: 2)
- Respiratory irritation: Irritating (See results of sub-chronic studies by inhalation in rat and mice)

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

1- Skin irritation:

There are several skin irritation studies, all showing evidence of HMD corrosivity.The study identified as the key study (Ladies, 1998), 35%, 70% and 85% of HMD aqueous solutions were corrosive and were assigned to Packing Group II (OECD 435, in vitro test, Kr: 1). The results were confirmed in vivo by a test conducted according to the Directive 92/69/EEC, B.4 (Marzin, 1978, Kr: 2), the mean scores were 4 for both erythema and oedema and all these effects were not reversible at 72 hours after application..

2- Eye irritation:

Eye irritation is severe following HMD contact. In an eye irritation/corrosion study (Marzin, 1978, Key study, Kr: 2), four rabbits were treated with 0.1 g of HMD. The method followed is similar to 92/69/EEC, B.5. The mean irritation scores for all animals within 24, 48 and 72 hours was 4 for corneal opacity and 2 for iris without reversibility after 72-hour observation period. Due to the corrosivity of the HMD, the study was finished after 3 days of exposure. Based on this study, HMD is highly irritating to eyes and induced irriversible effects (the worst case).

3- Respiratory irritation: HMD is classified with STOT SE3 in the CLP (1272/2008). In sub-chronic studies conducted in rats and mice exposed by inhalation (NTP, 1993 and Ben-Dyke, 1981), clinical signs were primarily related to upper respiratory tract irritation and included dyspnea and nasal discharge both in rats and mice. Moreover, clinical signs were accompanied by histopathological examinations showing irritation in the nasal cavity and larynx in both species from 31 mg HMD/m3 (see "7.5.3 Repeated dose toxicity: inhalation").

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: highly irritating

Effects on respiratory irritation: irritating

Justification for classification or non-classification

Hexamethylenediamine (Cas: 124 -09 -4) is classified in the Annex VI (Table 3.1 and 3.2) of CLP regulation (1272/2008) as:

- Skin Corr. 1B (H314)

- and STOT SE 3 (H335)

According to the results of key studies, no self classification is proposed.

Remark/eye irritation:

Based on the key study (cited above), HMD is considered in Category 1 (irreversible effects on the eye) according to the CLP Regulation (Regulation (EC) No 1272/2008). Since HMD is classified as Skin Corr. 1B (H314: Causes severe skin burns and eye damage) the corresponding hazard statement for serious eye damage (H318) does not need to be used for labelling to avoid redundancy.