Registration Dossier

Administrative data

Description of key information

The substances of the amine heads category showed corrosive effects when appplied to the skin of rabbits or tested in an in vitro skin corrosion assay. When applied to the rabbits eye the substances caused irreversible damage. 

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:
no study available

Additional information

Skin irritation

Two skin irritation/corrosion test were conducted each using six rabbits. The animals were exposed to 0.5 ml of MPMD on the clipped skin for 4 h (mostly under occlusive conditions). Within a reliable study (with restrictions) MPMD was washed from the skin already after three minutes. The skin reactions were observed for 48 h after the initial exposure. In all tests all of the tested animals showed skin corrosion, at all reading times (even after reading time 3 minutes after the 3 minute exposure).

 

Four skin irritation/corrosion tests were conducted each one using between three and eight rabbits and having DCH as test material. The animals were exposed to 0.5 or 1 ml or 500 mg of test substance on the clipped skin for up to 24 h (1 min, 3 min, 5 min, 15 min, 4 h, 20 h, under semi-occlusive or occlusive conditions). The skin reactions were observed for up to 28 days after the initial exposure. All of the tested animals showed skin corrosion.

 

For the purpose to determine skin corrosion potential of HMD an in vitro assay according to the OECD 435 was performed. Aqueous dilutions of HMD at 35%, 70% and 85% were evaluated for skin corrosion potential using thein vitroInternational Corrositex assay. Under the conditions of this test, all of the tested HMD aqueous solutions were corrosive.

Eye irritation

An eye irritation/corrosion test was performed with three rabbits. The animals were exposed to 0.1 ml of MPMD. In the first animal (eye washed for 1 min after 20 seconds of exposure) the test substance caused severe corneal irritation with large ulcer, moderate iritis, clouds of precipitate in the anterior chamber, and necrosis of the conjunctiva and outer lids. At ten days the eye appeared shriveled and at 11 days the animal was sacrificed. The eye of animal 2 was washed for 15 min after 20 seconds of exposure, this did not lessen the ocular effects in comparison to animal 1. The eye of animal 3 was not washed after test item application. The test substance caused immediate, complete corneal opalescence and necrosis of the conjunctiva and outer lid. Effects on the iris were not seen due to the severity of the corneal irritation; however, at 1-3 days the eye did not react to light. The rabbit was sacrificed at three days because of the obvious corrosive nature of the test material.

 

Eye irritation/corrosion tests for DCH were performed with either two or six rabbits. The studies were performed according to OECD 405 or a FDA guideline. The animals were exposed to 50 µl or 0.1 ml of DCH. In both studies it was concluded that the test substance washighly corrosive to the eyes of the animals.

 

Additionally there was an eye irritation/corrosion test performed for HMD (similar to 92/69/EEC, B.5 guideline). 4 New Zealand White rabbits were treated with HMD. 0.1g of HMD was applied onto rabbit eyes. Scores were recorded for cornea, iris, conjunctivae and chemosis at 1, 24, 48 and 72 hours. Maximum scores were achieved for all endpoints evaluated and all effects were not reversible at 72 hours after application. Under the test conditions, HMD is considered to cause serious eye damage which is non-reversible.


Justification for selection of skin irritation / corrosion endpoint:
Most suitable study record available for this endpoint.

Justification for selection of eye irritation endpoint:
Most suitable study record available for this endpoint.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

According to the results of available data for the members of the amine heads category as well as the knowledge about the very alkaline nature of the category members (i.e. pH > 11.5), these substances do fulfill the criteria to be classified as skin corrosive substance following criteria of Regulation (EC) No. 1272/2008 (CLP) as well as Council Directive 67/548/EEC (risk phrase 35). Using the most conservative results reported the substances have to be classified in subcategory 1A (CLP).

According to the results of available data the test item fulfills the criteria to be classified to cause irreversible damage to the eyes (Cat. 1) following the criteria of Regulation (EC) No. 1272/2008 (CLP). Based on the criteria set in Council Directive 76/548/EEC the submission substance as to be classified as Irritant, which causes serious damage to eyes (R41).