Registration Dossier

Administrative data

Description of key information

Paradimethoxybenzene is slightly irritating to the eyes and not irritating to the skin in tests on rabbits, following OECD guidelines.

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:

Four studies were available and two studies with validity 1 were selected as key studies.

In the first primary dermal irritation study (RCC study number B16075), New Zealand White rabbits (1 male and 2 females) were dermally exposed to 0.5 g of Paradimethoxybenzene moistened with purified water for 4 hours to 6.25 cm² on left flank. Test sites were covered with a semi-occlusive dressing for 4 hours. Animals then were observed for 72 hours. Irritation was scored according to the EU classification criteria.
The scores were 0 for edema and 0 for erythema.

In the second one (Clariant, 1988), animals were tested with the same manner.

The mean scores at 24, 48 and 72 hours were 0 for edema and 0,2 for erythema.

In these studies, Paradimethoxybenzene is not a dermal irritant according to the EU classification criteria.

Eye:

Two studies with validity 1 were selected as key studies.

In the first primary eye irritation study (RCC study number B16086),0.1 gof Paradimethoxybenzene was instilled into the conjunctival sac of left eye of New Zealand White rabbits (1 male and 2 females). Animals then were observed for 72 hours. Irritation was scored according to the EU classification criteria.
The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for chemosis, corneal opacity and iris were
0.00for all three animals.

The individual mean scores for the conjunctivae were 0.33, 0.33 and 0.67, respectively.

No abnormal findings were observed in the cornea or iris of any animal at any of the measurement intervals.

In the second primary eye irritation study (Hoechst, 1988), 0.1 gof Paradimethoxybenzene was instilled into the conjunctival sac of left eye of New Zealand White rabbits (3 animals). Animals then were observed for 72 hours.

Irritation was scored according to the EU classification criteria.

The mean score was calculated across 3 scoring times, 24, 48 and 72 hours after instillation for corneal opacity, iris, redness and chemosis of the conjunctivae, separately.

The mean scores at 24, 48 and 72 hours for iris and chemosis were 0 for all three animals.

 

The individual mean scores at 24, 48 and 72 hours for the conjunctivae were 0.66, 0.33 and 0, and 0.33, 0 and 0 for corneal opacity.

No abnormal findings were observed in the cornea or iris of any animal at any of the measurement intervals.

In these studies, Paradimethoxybenzene is not an eye irritant based on the EU classification criteria.


Effects on eye irritation: slightly irritating

Justification for classification or non-classification