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Description of key information

Skin irritation/corrosion: 
Skin irritation/corrosion was assessed with two different studies referring to OECD guidelines (OECD N°439 : In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method and OECD N°431 : In Vitro Skin Corrosion: Human Skin Model Test). According to these studies, the test item is considered nor as an irritating neither as a corrosive substance.
Eye irritation:
Eye irritation was assessed with a BCOP study referring to EEC validation study (contract ref. B91/B4-3081/013188, 1991; Gautheron et al., 1994) with some modifications (Vanparys et al., 1993). According to this study, the test item is observed to be moderately irritating.

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:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

The test substance was applied to EPISKIN human epidermis skin constructs. The constructs consisted of normal, human-derived epidermal keratinocytes, which had been cultured to form a multilayered, highly differentiated model of the human epidermis with a functional multilayered stratum corneum. The cell viability was determined by mitochondrial dehydrogenase activity, assessed by the reduction of MTT (3-(4,5-dimethylthiazol-2-yl)-2, 5-diphenyltetrazolium bromide) to a soluble, coloured, formazan product. The prediction model uses the percentage viability values (compared to negative control viability) to identify irritant and non-irritant substances.

The test substance, JNJ-31052047-ABI, elicited a mean tissue viability of 98.5±3.2% and was predicted as non-irritant to the skin.

Skin Corrosion:

The test substance was applied for three minutes and one hour to the EpiDerm™ threedimensional human skin model. The model consisted of normal, human-derived epidermal keratinocytes, which had been cultured on 0.6 cm² inserts to form a multilayered, highly differentiated model of the human epidermis with a functional multilayered stratum corneum. The cell viability of the multi layers was determined by mitochondrial dehydrogenase activity assessed by the reduction of MTT (3 (4,5-dimethylthiazol-2-yl)-2, 5-diphenyltetrazolium bromide) to a soluble, coloured, formazan product. The formazan produced was quantified by spectrophotometric measurement. The prediction model uses the percentage viability values (compared to negative control viability) at three minute and one hour exposure times to identify corrosive and non-corrosive substances.

The test substance, JNJ-31052047-ABI, elicited a mean tissue viability of 105.0% for 3 minute contact and 102.3% for 1 hour contact and was predicted as non-corrosive.

Eye irritation: The in vitro bovine corneal opacity-permeability (BCOP) assay assessed the ocular irritation potential of JNJ-31052047-ABI) by the use of isolated bovine corneas. Both opacity and permeability were measured and the resulting objective values were combined to calculate the ‘in vitro score’. When tested as a 20 % (w/w) suspension, JNJ-31052047-ABI induced a moderate increase in corneal opacity and no increase in permeability. An in vitro score of 42.3 ± 11.3 was calculated and classified the 20 % (w/w) formulation as a moderate eye irritant. Based on the obtained results, the test item is classified as a moderate eye irritant when tested in vitro under the conditions described in this report.


Justification for selection of skin irritation / corrosion endpoint:
Both the irritation and corrosion studies conclude on the non-irritating/non-corrosive state of this substance.

Justification for selection of eye irritation endpoint:
Under the experimental conditions reported, the test item T0033325 is considered to be a moderately irritating substance.

Effects on eye irritation: moderately irritating

Justification for classification or non-classification

Skin irritation/corrosion:

According to the two in vitro skin irritation and corrosion studies, the test item T0033325 (JNJ-31052047-ABI) is considered nor as a skin irritating neither as a skin corrosive substance.

Eye irritation: In vitro eye irritation study (BCOP) suggests that the test item is moderetely irritating. According to the DSD and CLP Regulations, the substance should be classified as R36 and eye irritant category 2 (H319).