Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
4 to 18 June 2007
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Recent GLP guideline compliant study, reported in summary form

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Dimethylolpropionic acid, obtained from VUP a.s. Prievidza.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
The animals were male and female New Zealand White rabbits, supplied by Velaz (Prague). At the start of the study animals weighed 2-2.5 kg. The rabbits were acclimatised for 21 days, during which time the health status of the rabbits was observed. The animals were housed individually in suspended metal cages, and had free access to mains drinking water and food. The animal room was maintained at a temperature of 17-20°C, and relative humidity of 49-56%. The animals were subjected to a 12 hour light: 12 hour dark cycle.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
500 mg of the test material was applied to the skin
Duration of treatment / exposure:
Four hours
Observation period:
72 hours following patch removal
Number of animals:
2 males and 1 female.
Details on study design:
The study was conducted according to OECD guideline 404. The day before the test the dorsal flank of each rabbit was clipped free of fur using veterinary clippers. Only animals with a healthy intact epidermis (assessed by gross observation) were selected for the study.
On the day of the test a suitable test site was selected on the back of each rabbit. A quantity of 500 mg of the test material was introduced under a 2.5x2.5 cm gauze patch and placed in position of the shaved skin. The patch was secured in position with a strip of surgical adhesive tape.
Four hours after application the patches were removed and any residual test material was removed by gentle swabbing with cotton wool soaked in distilled water. The test sites were examined for signs of primary irritation 1 hour after patch removal, and 24, 48 and 72 hours later.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-72 hours
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 5 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-72 hours
Score:
0
Max. score:
0
Remarks on result:
other: No effects seen
Irritant / corrosive response data:
The test substance produced a very slight erythema in all 3 rabbits, noticeable 24 hours after patch removal and persisting for 3-4 days following patch removal. No other signs of irritation were noted.
Other effects:
None reported.

Any other information on results incl. tables

Dermal reactions

Observation

Timepoint

1h

24h

48h

72h

Mean (24-72h)

4d

5d

Erythema

0,0,0

1,1,0

1,1,0

1,1,0

0.67

1,0,0

0,0,0

Oedema

0,0,0

0,0,0

0,0,0

0,0,0

0.00

0,0,0

0,0,0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance was not irritating to the skin.
Executive summary:

Dimethylolpropionic acid was applied to the shaved intact skin of 3 New Zealand White rabbits, under a semi-occlusive patch. The patch was left in place for 4 hours; upon removal of the patch any residual test material was removed by gently swabbing the skin with cotton wool soaked in distilled water. The test sites were examined for signs of primary irritation 1 hour after patch removal, and 24, 48 and 72 hours later. The test substance produced a very slight erythema in all 3 rabbits, noticeable 24 hours after patch removal and persisting for 3-4 days following patch removal. No other signs of irritation were noted. Data were not shown but the author reported that the substance congested and degreased the skin following repeat application.