Registration Dossier
Registration Dossier
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EC number: 700-534-0 | CAS number: 117172-56-2
Endpoint summary
Administrative data
Description of key information
Skin:
In an in vitro skin corrosion test (OECD 431) Intermediate 36 is considered not corrosive. To verify this result an additional in vivo study had been performed. The results of the in vivo study with rabbits showed that the test substance has to be classified Xi, R38 (Irritating to skin) according to 67/548/EEC, but not classified irritating to the skin according to Regulation (EC) 1272/2008 (GHS).
Eye:
The eye irritation potential of Intermediate 36 was investigated according to the ICCVAM Test Method (HET-CAM test). A mean irritation score of 0.0 was calculated, corresponding to a classification as “not irritant”.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin:
Based on the results obtained in an In Vitro Skin Corrosion: Human Skin Model Test (OECD 431, adopted 13. Apr. 2004), Intermediate 36 is considered not corrosive. To verify this result an additional in vivo study had been performed.
In additon, albino New Zealand White rabbits were treated with Intermediate 36 in an in vivo skin irritation study.
A semi-occlusive application procedure was used. The test item was administered undiluted, at a single dose of 0.5 mL for a period of 4 hours. Gauze was placed onto the hairless skin of the rabbit, test item was applied to the gauze, additional gauze was placed over the test item and an adhesive clear plastic patch was applied. The trunk was wrapped in clear plastic with medical tubing used to hold the patch in place. The untreated skin of each animal served as control.
There was no mortality or systemic clinical changes related to Intermediate 36 administration.
There was no effect of treatment on body weight.
At 1 hour after patch removal, very slight erythema (score 1) was observed in 3/3 animals and very slight oedema (score 1) was observed in 3/3 animals.
At 24 hours after patch removal, well defined erythema (score 2) was observed in 3/3 animals and very slight oedema (score 1) was observed in 3/3 animals.
At 48 and 72 hours after patch removal, well defined erythema (score 2) was observed in 2/3 animals, very slight erythema (score 1) was observed in 1/3 animal and very slight oedema (score 1) was observed in 3/3 animals.
Hard surface of the skin was also noted in one animal 72 hours after the patch removal.
At 1 week after patch removal, dry surface of the skin and flaking was noted in 3/3 animals.
At 2 weeks after patch removal, there were no observed signs on the skin of the treated animals. Accordingly, the study was terminated after the observation performed at 2 weeks.
The individual mean scores of the 3 animals (considering readings at 24, 48 and 72 hours) for erythema were 1.33, 2.00 and 2.00.
The individual mean scores of the 3 animals (considering readings at 24, 48 and 72 hours) for oedema were 1.00, 1.00 and 1.00.
This results in the conclusion that the test substance has to be classified Xi, R38 (Irritating to skin) according to 67/548/EEC, but not classified irritating to the skin according to Regulation (EC) 1272/2008 (GHS).
Eye:
The eye irritation potential of Intermediate 36 was investigated according to the ICCVAM Test Method Evaluation Report: Appendix G, ICCVAM recommended HET-CAM Method Protocol (Nov. 2006) by detection of damages in blood vessels under the chorionallantoic membrane of incubated chicken eggs (nine days old). A mean irritation score of 0.0 was calculated, corresponding to a classification as “not irritant”.
Justification for classification or non-classification
Skin:
The classification and labelling is based on the results of the in vivo study.
The individual mean scores of the 3 animals (considering readings at 24, 48 and 72 hours) for erythema were 1.33, 2.00 and 2.00.
The individual mean scores of the 3 animals (considering readings at 24, 48 and 72 hours) for oedema were 1.00, 1.00 and 1.00.
This results in the conclusion that the test substance has to be classified Xi, R38 (Irritating to skin) according to 67/548/EEC, but not classified irritating to the skin according to Regulation (EC) 1272/2008 (GHS).
Eye:
Based on the results of the in vitro eye irritation study (HET-CAM test), the test substance is not classified irritating to the eye according to 67/548/EEC and according to Regulation (EC) 1272/2008 (GHS).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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