Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1970
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This study design follows OECD guideline 404 and extends requirements in certain details (e.g exposure time, number of animals, scarified skin, occlusive instead of semi-occlusive). The conduct and the findings of the study are well reported. However, some individual data were not included in the report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
1970

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
increased exposure time, larger number of animals, scarified skin, occlusive instead of semi-occlusive conditions
GLP compliance:
no
Remarks:
performed before OECD GLP regulation became effective

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
The acute skin irritation potential of DHA was investigated in six male White New Zealand rabbits following application either on intact (3 animals) or scarified skin (3 animals).
Mean body weight at start of experiment: 2.50 kg

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
water
Controls:
yes, concurrent vehicle
Amount / concentration applied:
0.5 g moistened with water
Duration of treatment / exposure:
24 h
Observation period:
7 d
Number of animals:
intact skin: 3 animals
scarified skin: 3 animals
Details on study design:
The acute skin irritation potential of DHA was investigated in six male White New Zealand rabbits following application either on intact (3 animals) or scarified skin (3 animals). Aliquots of neat DHA (0.5 g) were moistened with water and applied to the intact or scarified skin of each rabbit for a 24-hour period under occlusive conditions. The rabbits were examined for skin reactions after removal of the patches daily for seven days.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h
Score:
1
Max. score:
1
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48h
Score:
0.83
Max. score:
1
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72h
Score:
0.13
Max. score:
1
Reversibility:
fully reversible within: 4 days
Remarks on result:
other: Scores are evaluated from the findings described in the report
Irritation parameter:
edema score
Basis:
mean
Time point:
other: all time points
Score:
0
Max. score:
0
Irritant / corrosive response data:
Directly after removal of the occlusive patches a slight reddening was observed in all rabbits both with intact or scarified skin up to day 2 (5 animals) or day 4 (one animal). Thereafter, all animals were without findings
Other effects:
no

Any other information on results incl. tables

Skin reactions were evaluated and graded according to FDA appraisal. The scores were assessed from the description of effects provided in the report.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: US CPSC / US FDA
Conclusions:
Based on this study DHA is considered not to be irritating to the skin.
Executive summary:

The acute skin irritation potential of DHA was investigated in six male White New Zealand rabbits following application either on intact (3 animals) or scarified skin (3 animals). Aliquots of neat DHA (0.5 g) were moistened with water and applied to the intact or scarified skin of each rabbit for a 24-hour period under occlusive conditions. The rabbits were examined for skin reactions after removal of the patches daily for seven days. Skin reactions were evaluated and graded according to FDA appraisal. Directly after removal of the occlusive patches a slight reddening was observed in all rabbits both with intact or scarified skin up to day 2 (5 animals) or day 4 (one animal). Thereafter, all animals were without findings.

Based on this study DHA is considered not to be irritating to the skin.