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Administrative data

Description of key information

Following the indications of column 2 of REACH Annex VIII, the most appropiate route for testing chosen has been oral route. An OECD 422 study has been selected to be performed and has allowed to determine a NOAEL which has been used to do the Chemical Safety Assessment and derive the DNELs for each route.

For dermal, based on exposure considerations and the available toxicological information, testing in a 28-days by oral route has been considered sufficient.

For inhalation,  the study does not need to be conducted because the exposure of humans via inhalation is unlikely taking into account the vapour pressure of the substance.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
300 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
OECD 422, GLP compliant

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Repeated dose oral toxicity information is derived from a 28 days oral toxicity study conducted in rats. The oral administration of the substance to rats by gavage, at dose levels of 750, 300 and 30 mg/kg bw/day, resulted in treatment-related changes at 750 and 300 mg/kg bw/day. Effects at 300 mg/kg bw/day were considered not to represent an adverse effect. Therefore a ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was considered to be 300 mg/kg bw/day.

The observed effects at the observed concentrations are considered not to support classification for specific target organ toxicity following repeated exposure, and the substance does not meet the criteria for classification for this endpoint according to CLP (Regulation 1272/2008/EC).

For derivation of DNEL the calculated and available NOAEL has been chosen.

According to the CSA performed and the risk characterisation values obtained no further testing is proposed for this substance.

No test substance related systemic toxicity has been reported for dermal toxicity. The following points have been taken into account:

Exposure: When used in manufacturing or at industrial/professional sites it is assumed that risk management measures are in place and the dermal contact is not significant.

The exposure of general population to this substance by dermal route is significant at low concentrations and being included in the support (paper, textile or leather). The dyeing properties of this substance are based on the linking of the material to the substrate. There are specific migration tests to confirm that the dye won’t migrate to the human skin by contact with the dyed materials. The migration tests reproduce common conditions and circumstances where could be expected this migration effect, e.g. Acidic and basic sweat, fat, butter, etc.

Toxicological information: The acute dermal toxicity studies show that the systemic availability via this route is low, suggesting that the absorption by dermal route is low. The substance is not classified as skin irritant, thus it is not expected that absorption will be favoured by this effect. In an old test of 1972, a repeated patch test performed with two hundred volunteers showed no effects and the study reached to the conclusion that with a 95% of confidence, a minimum of 98. 34% of a general population would not be sensitized dermally by this material.

No test substance related systemic toxicity has been reported for inhalation toxicity. This substance has a low vapour pressure and it is a solid, so that normal processing and use conditions will not generate inhalation exposure.

Justification for classification or non-classification

Based on the results of repeated oral exposure, the observed effects at the used concentrations are considered not to support classification for specific target organ toxicity following repeated exposure, and the substance does not meet the criteria for classification for this endpoint according to CLP (Regulation 1272/2008/EC).