Registration Dossier
Registration Dossier
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EC number: 260-754-3 | CAS number: 57472-68-1
Endpoint summary
Administrative data
Description of key information
Skin
In vivo
- Rabbit, 4 h, semiocclussive: irritating to skin (BASF AG 1987, Val. 2)
- Rabbit, 24 h, occlussive: irritating to skin (WIL Res Labs Inc. 1982, Val. 2)
- Rabbit, 4 h, semiocclussive: irritating to skin (Huntingdon 1993, Val. 1)
- Rabbit, 4 h, semiocclussive: mildly irritating to skin (Huntingdon 1998, Val. 1)
- Rabbit, 4 h, semiocclussive: not irritating to skin (Huntingdon 2002, Val. 1)
Eye
In vivo
- Rabbit, substance was not washed out: Risk of serious damage to eyes (MB Research Labs 1998a, Val. 1)
- Rabbit, substance was not washed out: Risk of serious damage to eyes (MB Research Labs 1998b, Val. 1)
Respiratory system
No data available
Key value for chemical safety assessment
Additional information
There are valid in vivo data available for the assessment of the skin and eye irritation potential of DPGDA.
Skin
A skin irritation test was performed with three Vienna White rabbits under semiocclusive conditions (BASF AG 1987, acc. OECD 404).
A 4-hour exposure to ca. 0.5 ml of the undiluted test substance produced a mean score for erythema of 2.33, and a mean
score for edema of 0.22 regarding the 24, 48 and 72 h reading time points. The scores obtained for edema were fully reversible within
72 hours and those for erythema were fully reversible within 15 days in all treated animals.
Irritating effects were also seen in a second study, which was conducted with New Zealand White rabbits under occlusive conditions
according to the method of Draize (WIL Res Labs Inc. 1982, Val. 2). After an appplication time of 24 hours the mean score of 6
animals for erythema (24 and 72 hour value) was 2.59, the mean score for edema (24 and 72 hours) was 3.67. The effects observed
for erythema as well as for edema were not fully reversible within the observation period of 7 days.
In another study, also conducted according to OECD 404 with New Zealand White rabbits, irritating effects were observed
(Huntingdon 1993, Val. 1). Scores for both erythema and edema each were >/= 2 in 2/3 animals and in 1/3 animals each the effects
observed were not fully reversible within the observation period of 14 days.
Mildly irritating effects were seen in another study which was also conducted according to OECD guideline 404 (Huntingdon 1998,
Val. 1).The mean score for erythema (24/48/72 hour value) was 1.89, the mean score for edema (24/48/72 hours) was 1.45. The
effects observed were fully reversible within 7 days for edema and within 12 days for erythema.
Slight to moderate effects were observed in another study which was also conducted according to OECD guideline 404 (Huntingdon
2002, Val. 1).The individual scores for erythema (24/48/72 hour values) were 2, 1.33 and 1, the mean scores for edema (24/48/72
hour values) were 1.67, 1 and 0.The effects observed for erythema and edema were fully reversible at least within 15 days.
Eye
In two studies, both conducted according to OECD 405 and under GLP conditions severe effects were observed (MB
Research Labs 1998 a and b, both Val. 1). In the first study the mean score for corneal opacity was 2, regarding the reading time
points 24-48-72 h, the mean score for iritis was 1, regarding the reading time points 24-48-72 h, the mean score for conjunctiva
redness was 2.16 and the mean score for conjunctiva chemosis was 3.11, regarding the reading time points 24-48-72 h. The effects
observed were not fully reversible within 21 days.
In the second study corneal opacity, noted in 3/3 eyes (scores 2/2/2, regarding the reading time points 24-48-72 h), persisted to day
14 in two eyes. Iritis, noted in 3/3 eyes (scores 1/0.67/1, regarding the reading time points 24-48-72 h), cleared by day 7 in two
eyes. It was not possible to determine the iritis in one eye on day 14 due to the severity of the corneal responses. Conjunctival
irritation, noted in 3/3 eyes (scores 2.67/1.67/2 for rednes and 3.33, 2.33 and 3 for chemosis, regarding the reading time points
24-48-72 h), persisted to day 14 in one eye.
Respiratory system
No data available
Justification for classification or non-classification
Skin
Due to the skin irritation effects observed, DPGDA has to be classified as skin irritant Category 2 (H315) according to GHS-criteria (1272/2008/EC).
Eye
Due to the severe effects observed on the eyes of the rabbits, DPGDA has to be classified as Category 1 (H318) according to GHS-criteria (1272/2008/EC).
Respiratory system
Actually, there are no data available for a classification regarding this endpoint.
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