Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
other: SCCNFP/0798/04
Adequacy of study:
supporting study
Study period:
na
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1987
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
additive
Test material form:
liquid - solid: mixture of
Remarks:
suspension : 2-hydroxy-1,4-napthoquinone in 0,5% aqueous methylcellulose
Details on test material:
2-Hydroxy-1,4-naphthoquinone suspended in 0.5% aqueous methylcellulose

Test animals

Species:
rabbit
Strain:
other: New Zealand Albino

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
other: 2% suspension in 0.5% aqueous methylcellulose (0.5 ml)
Controls:
not specified
Amount / concentration applied:
The substance was applied neat (0.5 g) to the right flank and as a 2% suspension in 0.5% aqueous methylcellulose (0.5 ml) to the left flank.
Duration of treatment / exposure:
4 hours
Observation period:
Cutaneous reactions were evaluated 1, 24, 48 and 72 hours after removal of the patches
Number of animals:
3
Details on study design:
not specified

Results and discussion

In vivo

Results
Irritation parameter:
other: irritation
Basis:
animal: 1,2,3
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: The substance could potential have provoked slight to moderate irritation

Applicant's summary and conclusion

Conclusions:
Orange staining due to the dye interfered with evaluation of erythema. No oedema was observed. The substance could potentially have provoked slight to moderate, but not severe irritation.