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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study performed before test guidelines and GLP principles were in place. However missing information and shortcomings in description of the methods. Observation time was only 48 hours, observation time was not extended until effects were reversed. Test substance applied occlusively instead of semi-occlusive as current guideline recommends. No details on test substance (Lot/Batch number; purity).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
occlusive instead of semi-occlusive application; exposure period 24 hours intstead of 4; observation time only at 0 and 48 hours, not elongated until effects reversed.
GLP compliance:
no
Remarks:
Study performed before GLP principles were in force

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No details given.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: not described
- Age at study initiation: adult (no further details)
- Weight at study initiation: not described
- Housing: not described
- Diet (e.g. ad libitum): not described
- Water (e.g. ad libitum): not described
- Acclimation period: not described

ENVIRONMENTAL CONDITIONS
No details given on any of the parameters

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved (24 hours before test); skin left intact or abraded. Only results of intact skin summarized.
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5g
Duration of treatment / exposure:
24 hours
Observation period:
48 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.54cm x 2.54cm
- Type of wrap if used: surgical patch wrapped in an impervious material

REMOVAL OF TEST SUBSTANCE
- Washing: not described
- Time after start of exposure: 24 hours

SCORING SCHEDULE: 24 and 72 hrs. after application.

SCORING SYSTEM: According to Draize (J. Pharmacol. 82 (1944) 377-390), comparable to system described in current OECD/EC guidelines.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 6 rabbits with intact skin
Time point:
other: 48 hours after removal
Score:
0.2
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 rabbits with intact skin
Time point:
other: 48 hours after removal
Score:
0
Max. score:
4
Irritant / corrosive response data:
Very slight erythema was observed directly and 48 hours after removal of the bandage, no oedema was observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a dermal irritation study with 6 rabbits, minor erythema was seen. Based on this study the substance is not irritating according to CLP Regulation (EC) No 1272/2008.
Executive summary:

A dermal study with 6 rabbits was performed equivalently to current OECD guidelines. At 48 hrs. after removal of the substance, very slight erythema was observed in one rabbit. Since only minor effects were observed in only one of six animals, the substance is not irritating according to CLP Regulation (EC) No 1272/2008.