Registration Dossier

Administrative data

Description of key information

The registration substance is corrosive to skin and severly irritating to eyes. 

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

Assessment of skin irritation

The skin irritation/corrosion property of the registration substance is derived based on the read-across approach.

There are six studies available for skin corrosion/irritation, five are in-vivo and one in-vitro. 

- The read-across supporting substance CAS 71786 -60 -2 was investigated for its irritancy potential to the skin in rabbits according to the OECD 404 . A single 4 -hour, semi-occluded application of the test material to the intact skin of three rabbits produced persistent moderate to severe irritation. Due to the persistency of the observed effect, the substance is to be clssified as skin corrosive.

- The read-across supporting substance CAS 71786 -60 -2 was investigated for its skin irritation property in domestic swine following the principles of OECD guideline 404.

0.5 ml of the pure test material was applied to the skin of three domestic swine for four hours. Parameters for evaluation included body weights at initiation and study termination, daily observations for mortality and clinical signs of toxicity, and dermal scores recorded pretest and at 4, 24, 48, 72, 96, 120, 144, and 168 hours (7 days) post-dose.

No mortality or clinical signs of toxicity were observed during the 168-hour observation period.

Scab formation was observed on all three animals beginning at the 48 hour observation period and extending to the 168 hour observation period (slight/moderate scabbing). Exfoliation (slight/moderate) was observed on two of the three animals beginning at the 96 hour observation period extending to the 168 hour observation period. No signs of corrosion was found. The tested substance is skin irritating in domestic swine.

- The read-across supporting substance CAS 71786 -60 -2 was investigated for its skin irritation property according to the OECD Guideline 431.

The EPISKINTMwas treated with the test material for exposure periods of 3, 60 and 240 minutest and and viability of the tissue was investigated using MTT assay. No deviating values were obtained for treated and negative control substance treated tissues. The obtained result is indicative of non-corrosivity of the test material.

Comments on the results obtained in the in-vitro test systems: Generally, the fatty amine compounds are considered corrosive/irritating to skin based on the rabbit studies, in which the skin lesions became evident only after some days of observation period. Considering that there is actually no possibility to detect delayed tissue damage in the introduced in-vitro test system, the result obtained in this test system is likely to be of limited relevance.

- The read-across supporting substance CAS 71786 -60 -2 was investigated for its skin irritation property according to the OECD Guideline 404.

3-minute and 1-hour semi-occluded applications of the test material to the intact skin of one rabbit produced no corrosive effects.

A single 4-hour, semi-occluded application of the test material to the intact skin of one rabbit produced moderate to severe erythema, slight oedema and a hardened, dark brown/black coloured scab which prevented accurate evaluation of erythema and oedema.Well-defined erythema surrounding the scab was also noted. Thickening of the skin was noted at the 14-Day observation. Based on the severity and the effects noted 14 day after the treatment, the test material is to be classified as skin corrosive.

- The read-across supporting substance CAS 71786 -60 -2 was investigated for its skin irritation property according to the OECD Guideline 404. The test material was applied to rabbits semi-occusively for 4 hours. Erythema and oedema of scores 4 were obtained within the observation period of 3 days and one animal exhibited bloody skin lesion. The effects regressed within the observation period of 19 days. The substance is to be classified as skin corrosive after 4 h treatment.

- The read-across supporting substance CAS 71786 -60 -2 was investigated for its skin irritation property according to the OECD Guideline 404.

A single 30 minute, semi-occluded application of the test material to the intact skin of one rabbit induced erythema and edema, the highest scores being 3 and 2 respectively within the observation time of 72 hours. The observed effects regressed and at the end of the observation time of 14 days two animals exhibited minimal effects. The test material was irritating to skin after 30 minutes application.

Assessment of eye irritation

The eye irritation property of the registration substance is derived based on the read-across approach.

There are three rabbits eye irritation studies available. The obtained results are consistently indicating that the registration substance is likely to cause severe damage to eyes upon eye exposure.

-The read-across supporting substance CAS 71786 -60 -2 was investigated for its eye irritation property in rabbits. The method used generally followed that described in the OECD Guidelines 405 . A single application of the test material to the non-irrigated eye of six rabbits produced clear corneal opacity, moderate iritis, and severe conjunctival irritation. The conjunctivae were obviously swollen causing almost complete closure of the eyelids. Observations were made up to 72 h after exposure; therefore no information is available on reversibility but it is expected that the changes may not fully reversible after 21 days.

- The read-across supporting substance CAS 71786 -60 -2A was investigated for the irritancy potential to the eye of the rabbit. The method used generally followed that described in the OECD Guidelines 405. A single application of the test material to the non-irrigated eye of one rabbit produced severe ocular reactions, and the animasl were killed 2 days after instillation.

-The read-across supporting substance CAS 71786 -60 -2 was investigated for its eye irritation property in rabbits . The rabbits were given 0.1 ml of the test substance and the treated eyes were washed after 30 seconds and 4 seconds and the effects in eyes were evaluated according to the Draiz scores. The test substance is irritating to eyes when washed after 30 seconds and not irritating when wahsed after 4 seconds.

Respiratory tract irritation

There are no studies to assess the respiratory tract irritation of the registration substance.

The registration substance is corrosive to skin and severly irritating to eyes, so that comparably hazardous profile can be anticipated also for the respiratory tract. The registration substance is likely to cause immediate irritating sence and lesions on the direct contact site upon inhalation.


Justification for selection of skin irritation / corrosion endpoint:
Weight of evidence approach: obtained results in five in-vivo studies are consistent

Justification for selection of eye irritation endpoint:
Weight of evidence approach; obtained results in three available studies are consistent

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

The irritation/crrosion property of the registration substance, 2,2'-(C12-14 evennumbered alkyl imino) diethanol, is derived based on the read-across approach.

The registration substance is likely to be skin corrosive and should be classified as Category 1C.

It is likely to cause serious irreversible damage to eyes and should be classified as Category 1.