Registration Dossier

Administrative data

Description of key information

- Skin irritation: not irritating (BASF AG, 1981; 79/164)
- Eye irritation: not irritating (BASF AG, 1981; 79/164)

Key value for chemical safety assessment

Additional information

Skin irritation

In the chosen key study (BASF AG, 1981; 79/164) performed according to the Fed. Reg. 38 No. 187, § 1500.41 protocol, 0.5 ml undiluted 4 -methoxybenzaldehyde was applied to the shaved skin site of each, 3 female Vienna White rabbits under occlusive conditions for 24 hours (area of test site: 2.5 x 2.5 cm2). The skin reaction was observed from 1 hour up to 8 days observation period. Evaluation of the skin reactions according to the Draize scoring system revealed a slight skin irritation. Mean 24 -48 -72 -hour scores were 1, 0.6 and 2 for erythema and 0.67, 0 and 0.67 for edema for each animal respectively. The skin reactions were fully reversible during the observation period except for 1 animal showing slight erythema at day 8. A tendency for reversibility was present in this animal. The treatment protocol, i.e. 24 hour test substance application under occlusive conditions represents a worst case and skin reactions after a 4 hour test substance application (see below) was fully reversible within 24 hours.

In a supportive study (BASF AG, 1981; 79/164) study performed under occlusive conditions, 0.5 ml unchanged test substance was applied to the shaved skin site of 2 female Vienna White rabbits for 4 hours (area of test site: 2 x 2 cm2). The skin reaction was observed from 1 hour up to 8 days observation period, and evaluated according to the the Draize scoring system. Erythema and edema reactions were observed in both animals directly after treatment, but were fully reversible within 24 hours.

In line, several studies from literature and secondary sources provide evidence for a low potential for skin irritation of 4 -methoxybenzaldehyde, including human patch test up to 20% 4 -methoxybenzaldehyde.

Eye irritation

In the chosen key study for eye irritation, performed according to the Fed. Reg. 38, No. 187, § 1500.42 protocol, 0.1 ml undiluted 4 -methoxybenzaldehyde was applied to the conjunctival sac of one eye of 3 male Vienna White rabbits each (no wash out) while the remaining untreated one served as negative control (BASF AG, 1981; 79/164). The ocular reactions were evaluated 1, 24, 48 and 72 hours after instillation according to the Draize scoring system. Signs of ocular irritation were observed directly after test substance administration, i.e. conjunctival redness (reversible within 72 hours) and chemosis (reversible within 24 hours). Mean score (24-48-72 hour timepoints) for conjunctiva redness was 0.33, 0.67 and 0.33 for each animal respectively.

Taken together , 4 –methoxybenzaldehyde showed no evident eye irritation potential.

 

Respiratory irritation

No data available.

Justification for classification or non-classification

The present data on skin and eye irritation do not fulfill the criteria laid down in 67/548/EEC and regulation (EU) 1272/2008, and therefore, a non-classification is warranted.