Registration Dossier

Administrative data

Description of key information

The test substance showed skin irritating effects in guinea pigs (Wang 1988) and in a Repeated Insult Patch Test with human volunteers (Monsanto 1982). In addition the test substance was classified as eye irritating in New Zealand albino rabbits (Monsanto Co 1973). In consequence, an existing classification with R36/38 (24 ATP)/ eye irritating cat. 2, skin irritating cat. 2 (regulation no. 1272/2008 GHS) is confirmed.

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)

Additional information

Skin

Non-human information

The skin irritation potential of the test substance MBS was evaluated with guinea pigs in a pre-test for a sensitizing assay. Two animals were treated with test substance preparations of 0.5 %, 2 %, 5 % and 10 % for 24 hours. Readings of skin reactions were performed at 1, 24 and 48 h after removal of the test material. The 5% and 10 % test substance preparation of MBS produced irritant reactions. The 5 % preparation however, caused a much weaker skin reaction than the 10 % preparation. The 0.5 % and 2 % concentrations as well as pure white petrolatum failed to produce any reactions (Wang 1988).

Human information

The potential for MBS to cause primary skin irritation and/ or sensitization was assessed in 49 human volunteers in a well conducted Repeated Insult Patch Test. The chemical was tested as a 75 % preparation in petrolatum. The test material elicited irritation in 31/49 individuals (Monsanto 1982a)

Eye

Non-human information

The eye irritating potential of the test substance MBS was evaluated in an eye irritation study with New Zealand albino rabbits (Monsanto Co 1973). 100 mg of the finely ground test substance was applied into the conjuntival sac of the rabbits. A 7-day observation period followed the application of the test substance. Eye response were scored in accordance with the Federal Hazardous substances Act (F.H.S.A.), 21 CFR, § 191.12 (1964).

The test substance was slight to moderate irritating to the rabbit eye (irritation mean score at 24, 48, and 72 hours: 6/110.0). Effects on the conjunctivae were noted in all animals at 24 hours (mean score 24 h: 12/110) but were reversible within 120 hours. The test substance was classified as an eye irritant according to F.H.S.A.


Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

Based on the findings of the above mentioned in vivo studies (see above) the test substance MBS is classified as skin irritant and eye irritant according to the classification criteria 67/548/EWG and regulation no. 1272/2008 (GHS).