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EC number: 248-654-8
CAS number: 27776-01-8
Skin irritation:In an in-vitro skin irritation study according to OECD 439 (Human Skin Model Test) 1,1-DPE was found to be irritative to the human skin.Untreated DPE 75 (75% diphenyl ethane) was tested for oral and dermal toxicity in groups of 3 male rats. Skin irritation studies were performed with 3 New Zealand White rabbits in each case. A primary irritation index (PII) of 4 was obtained indicating that this material is a moderate skin irritant. Untreated DPE75 is moderately irritating to the skin which is probably caused by a defatting action. In an in-vivo skin irritation study according to OECD 404, SAS-305, produced a primary irritation index of 2.3 and was classified as a MODERATE IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.SAS - 40, was found to be a moderate irritant to rabbit skin in an in-vivo skin irritation study according to OECD 404.Eye irritation:In-vivo eye irritation studies with 1,1-DPE were performed with 3 New Zealand White rabbits in each case. Untreated DPE 75 (75% diphenyl ethane) was placed into the eye of each rabbit by gently pulling the lower lid away from the eyeball to form a cup. Assessment of ocular irritation was made 1, 24, 48 and 72-hours after treatment using the Draize Scoring system. According to the CLP and DSD criteria this substance was not considered to be irritant to the eyes.The eye irritation potential of SAS-305 was tested in a GLP-compliant study according to OECD 405. SAS-305 was not irritant to the rabbits eye.SAS-40 was tested negative in an in-vivo eye irritation study according to OECD 405.For detailed read across rationale and justification within the diphenylmethane category see section 13, Read across document.
% Formazan production (Tissue 1)
% Formazan production (Tissue 2)
% Formazan production (Tissue 3)
% Formazan production Mean
Three tissues of the human skin mode! EpiDerm™were treated with
(phenylethyl)benzene for 60 minutes.
30 µL of the liquid test item (using a nylon mesh) were applied to
each tissue and spread to match the tissue size (0.63 cm2; as
indicated by supplier).
DPBS-buffer was used as negative control, 5% SDS-solution was used
as positive control.
After treatment with the negative control, the absorbance values
were within the required acceptability criterion of 1.0 < mean OD < 2.5.
The positive control showed clear irritating effects. Variation within
tissues was acceptable (<18 %).
andSex (Bodyweighl kg)
Time After Treatment
A study was performed to assess the irritancy potential of the test
material to the eye of the New Zealand White rabbit. The method used
followed that described in the OECD Guidelines for Testing of Chemicals
No. 405 "Acute Eye Irritation/Corrosion" (adopted 24 February 1987) and
Method B5 of Commission Directive 92/69/EEC (which constitutes Annex V
of Council Directive 67/548/EEC).
A single instillation of the test material to the non-irrigated eye of
three rabbits produced minimal conjunctival irritation in two treated
eyes. 3.The test material produced a maximum group mean score of 1.3.
The test material did not meet the criteria for classification as
irritant according to EU labelling regulations.
No data gaps were identified. The available data are adequate for risk
assessment and classification and labelling purposes.
detailed read across rationale and justification within the
diphenylmethane category see section 13, Read across document.
According to the CLP Regulation, the
substance is classified as:
Irritant, Category 2, based on positive skin irritation study according to
Eye irritation: Benzyltoluene is not
classified as eye irritant.
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.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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