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Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin Sensitisation

Hatoum & Johnson (1991) evaluated the dermal sensitization potential of isophthalic acid in a Buehler study using groups of 10 male Hartley Guinea Pigs. Isophthalic acid was applied once a week at a dose of 0.3 ml of a 30% (w/w) solution in DMSO for 6 hours during a 3 week induction period. Two weeks following the final induction dose, the animals received a challenge dose of 0.3 ml of a 30% (w/w) solution in DMSO, again for 6 hours. One of the ten test group animals showed a poistive reaction (according to the laboratory's criterion) of Grade 2 erythema. This reaction was seen at 24 hours but not at 48 hours, whcih would indicate an irritant rather than allergic response. A relatively high incidence of other reactions (Grade 1 erythema) was seen in all groups (treated, vehicle control and sham control) with similar incidences. The results of this study do not indicate that classification as a skin sensitiser is required.


Migrated from Short description of key information:
The results of a Buehler study do not indicate that classification as a skin sensitiser is required.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There is no indication from aninal studies or human experience that the substance is capable of causing respiratory sensitisation.


Migrated from Short description of key information:
There is no indication from aninal studies or human experience that the substance is capable of causing respiratory sensitisation.

Justification for classification or non-classification

One of ten test group animals in a Buehler study showed a positive reaction (according to the laboratory's criterion) of Grade 2 erythema. This reaction was seen at 24 hours but not at 48 hours, whcih would indicate an irritant rather than allergic response. A relatively high incidence of other reactions (Grade 1 erythema) was seen in all groups (treated, vehicle control and sham control) with similar incidences. According to the CLP Regulation EC Number 1272/2008, classification of the substance as a skin sensitiser is not required as a reponse of 15% or greater was not seen in this non-adjuvant study.