Registration Dossier

Administrative data

Description of key information

Allyl glycidyl ether (AGE) is irritating to skin and respiratory system and causes irreversible effects on the eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation:

In the key study (Hine et al. 1956), rabbits (n = 3) were exposed to undiluted AGE under a occlusive dressing during 24 hours and observed for 72 hours. Slight to well defined erythema and oedema were observed on intact skin at 24 and 72 hours after patch removal. One animal showed a severe oedema at 24 hours. No readings were done at 1 and 48 hours and no information on possible reversibility of the effects were given. These results were supported by another study (BASFAG VIII/219, 1968), where 2 rabbits were exposed to undiluted AGE (ca. 65% pure) for 1, 5, 15 min and 20 h under occlusive conditions. Slight erythema (score 1) was observed only in 1 animals after 24 h after 1, 5 or 15 min exposure, which was reversible within 48 h. After 20 h exposure, necrosis was observed along with erythema and edema was observed after 72 h in one animal. Moderate erythema and edema was observed in the second animal, which was not reversible within 8 days of observation period.

Taking all the presented data into consideration, AGE is classified as “irritant”, R38 according to EU standards and in Cat 2 according to GHS // CLP standards.

 

Eye irritation:

In an eye irritation study (Hine et al. 1956), performed with 3 rabbits where 0.1 ml undiluted AGE was instilled in one eye of each rabbit, the other eye being the control.were done after 1, 24 and 48 hours. However, individual scores for effects on cornea, iris and conjunctivae were not reported but overall scores given. Based on these scores AGE was considered to be severely irritating to the eyes. No information on possible reversibility of the effects was given. In another study (BASFAG VIII/219, 1968), no irritating effects were observed, where 50 µl of AGE was applied to the conjunctival sac of one eye of 2 rabbits. Based on the overall results, AGE is classified as R41 according to EU standards and in Cat 1 according to GHS / CLP standards.

 

Respiratory irritation:

No standard test method exists for the assessment of respiratory irritation. There is evidence that AGE causes respiratory irritation following repeated inhalation exposure. Additionally, in an inhalation test (Gagnaire et al. 1987), the upper respiratory tract effects resulting from a short-term exposure to AGE vapors in mice was conducted through oro-nosal route at concentrations of 8.9, 15.9, 19.6, 23.6, 29.6, 40.1 mg/m3 for 15 min. The parameter chosen as an index of sensory irritation was the reflex decreases in respiratory rate (50% decreases in the respiratory rate, RD50). There was dose related decrease in the respiratory rate observed and RD50 was established to be 26.6 mg/m3.

In the same study (Gagnaire et al. 1987), pulmonary toxicity effects resulting from a short-term exposure to AGE via tracheal cannulation were conducted in mice. A polyethylene cannula was inserted in the trachea and secured in anaesthetized mice and were exposed at concentrations of 490, 555.3, 760.6 and 863.3 mg/m3 AGE vapors for 120 min. Animals were allowed to recover from anesthesia for 75 min before the measurements of the respiratory rate (50% decreases in the respiratory rate, RD50). No recovery was observed after the end of exposure when tracheally cannulated mice were allowed to breathe fresh air. The 4 exposure concentrations produced an effect which developed slowly, the peak of the response occurring after 120 min of exposure; at this time of exposure the RD50 value was calculated to be 625.3 mg/m3.

AGE is already labeled as "R 37, Irritating to respiratory tract" according to current EU regulations based on the above results and general irritation potential of AGE.


Effects on skin irritation/corrosion: irritating

Effects on eye irritation: highly irritating

Effects on respiratory irritation: irritating

Justification for classification or non-classification

EU classification according to Annex I of Directive 67/548/EEC: Xi, R37/38, R41

CLP Regulation (EC No 1272/2008):

- Skin corrosion/irritation: Category 2

- Serious eye damage/eye irritation: Category 1

- Specific target organ toxicity, Single exposure: Category 3 (May cause respiratory irritation)