Registration Dossier
Registration Dossier
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EC number: 605-104-5 | CAS number: 157577-99-6
Endpoint summary
Administrative data
Description of key information
eye irritant , H318, cat.1
not skin 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:
- adverse effect observed (irritating)
Additional information
Skin irritation
One skin irritation in vitro, according to OECD 439 has been performed on Acid Black 234.
The test item was negative in the EpiDermTMmodel (i.e. not irritating).
Moreover, two in vivo test are available on similar substance 1, one study according to OECD 404 (Stahl, 1996) and one test following EU B4 (Clariant, 1997). Both tests have consistent results and show no skin irritation.
Eye irritation
One eye irritation in vitro test according to OECD 437 has been performed on Acid Black 234. The basic values for the IVIS calculation (opacity values) could not be measured because of colouring of corneas which were applied by the test item.
Therefore the In Vitro Irritancy Score (IVIS) for test item, Acid Black 234, could not be calculated.
For this reason the classification was not performed.
A further eye irritation in vitro test according to OECD 492 has been performed.
Under the experimental design, average viability of tissues treated by the test item Acid Black 234 was 6.8 % of negative control average value, i.e. viability was < 60 %.
The effect of the test item was positive in EpiOcularTM model (tissues were damaged).
According to the classification criteria, the test item, Acid Black 234, is identified as potentially requiring classification and labelling according to UN GHS – Category 1 or 2.
Therefore it was decide not to proceed with further in vivo test and classify the dye in the most conservative way as H318, cat.1.
An in vitro test according to OECD 437, on similar substance 1 is also available , Acid Black 210 Consortium (2014).
Since the test item was coloured, the mean opacity value is affected by the substance remaining on the corneal surfaces. No relevant increases in corneas permeability were recorded after treatment with the test item when compared to those of negative control
Finally, tests for eye irritation are also available on similar substance 2:
One Clariant test(1997) is available, following GLP and performed according to OECD 405.
All the effects have been properly assessed and described in detail. No effect has been reported for any end point after 6 days in any animal.
One BASF AG test (1984) is available according the OECD guideline 405 without deviations.
All the effects have been properly assessed and described in detail. No effect has been reported for any end point after 72 hours in any animal.
Justification for classification or non-classification
No classification for skin irritation/corrosion is warranted under Regulation 1272/2008
Classification as H318, cat.1 for eye irritation/corrosion is warranted under Regulation 1272/2008
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