Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted in compliance with GLP and according to the OECD guideline 404 (acute skin irritation/corrosion).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 1,1'-(2,2,4-trimethylhexane-1,6-diyl)bis-1H-pyrrole-2,5-dione and 1,1'-(2,4,4-trimethylhexane-1,6-diyl)bis-1H-pyrrole-2,5-dione
Molecular formula:
C17H22N2O4
IUPAC Name:
Reaction mass of 1,1'-(2,2,4-trimethylhexane-1,6-diyl)bis-1H-pyrrole-2,5-dione and 1,1'-(2,4,4-trimethylhexane-1,6-diyl)bis-1H-pyrrole-2,5-dione

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: males 14 weeks, females 15 weeks
- Weight at study initiation: males 2.4-2.6 kg, females 2.5 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3°C
- Humidity (%): 40-70%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: The test article was applied moistened with polyethylene glycol (PEG 400)
Controls:
no
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
The skin reaction was assessed at 1, 24, 48 and 72 hours and at 7 days intervals after the removal of the dressing, gauze patch and test article.
Number of animals:
3
Details on study design:
TEST SITE:
Approximately 24 hours before treatment, the dorsal fur was shaved with an electric clipper, exposing an area of approximately 100 square
centimeters ( 10 cm x 10 cm) .
On test day 1, 0.5 g of the test article was applied to approx. 6 cm2 of the intact skin of the shaved area. It was covered with a 3.0 cm x 3.0 cm patch of surgical gauze. The gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with an
elastic bandage.
REMOVAL OF TEST SUBSTANCE:
Four hours after the application, the dressing was removed and the skin was flushed with lukewarm tap water.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
male
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
male
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
female
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
male
Time point:
other: 24, 48 and 72 hours
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
male
Time point:
other: 24, 48 and 72 hours
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
female
Time point:
other: 24, 48 and 72 hours
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
Irritation:
MATMD showed a primary irritation score of 2.67, when applied to intact rabbit skin. Local signs (mean 1 hour to 7 days) consisted of grade
1.5 erythema and grade 0.6 edema. They were reversible until day 7.
Corrosion:
No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin. Slight scales were
observed in two animals, and moderate scales were observed in one animal on day 7 of observation.
Other effects:
Coloration:
In the area of application, brown staining of the treated skin by pigment or coloring of the test article was observed in all animals at each of the
measuring intervals.
Body weights:
The body weight gain of all rabbits was similar.
Clinical symptoms / Mortality:
No acute clinical symptoms were observed in the animals during the test period, and no mortality occurred.
Necropsy:
No necropsy was performed. All animals were killed and discarded.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Due to the mean irritation score of 2.67 when applied to the intact skin of rabbits the substance had to be classified as an irritant to the skin.
Executive summary:

Due to the mean irritation score of 2.67 when applied to the intact skin of rabbits the substance had to be classified as an irritant to the skin.