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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:
From 16 March to 06 July 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted according to OECD Guideline 404 in compliance with GLP. Analytical certificate not included in study report.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: HC:NZW
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Interfauna Ltd., UK
- Housing: Macrolon Type III cages
- Diet (e.g. ad libitum): Standard Ssniff K4 diet (Soest/Westfalen GmbH)
- Water (e.g. ad libitum): tap water
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2°C
- Humidity (%): ca. 50%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12:12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 µl undiluted substance
Duration of treatment / exposure:
4 h
Observation period:
14 d
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- % coverage:
- Type of wrap if used: substance applied rto hypoallergenic Hansamed bandage (Beiersdorf 2342), fixed with an elsatic bandage to provide semi-acclusive conditions

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results
Remarks on result:
other: see below section 'Irritant/corrosive response data'
Irritant / corrosive response data:
No effects observed in two animals. Grade 1 erythema seen until and including 48 h timepoint in one animal, no longer observed at 72 h. Overall score for this animal: 0.7
Other effects:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:
Under the conditions of the study, the substance was not irritating to skin.
Executive summary:

A study was conducted to determine the skin irritation potential of NPEO in rabbit according to OECD Guideline 404. 500 µl of undiluted test substance were applied by patch under semi-occlusive conditions to the shaved skin of 3 rabbits. The patch was removed after 4 h and the skin washed with water. Erythema, scarring and eodema were evaluated after 1, 24, 48, 72 h and 7 and 14 d according to the Draize scoring system. Other effects were also recorded. No effects observed in two animals. Grade 1 erythema was seen until and including the 48 h timepoint in one animal, but no longer observed at 72 h. The overall score for this animal was 0.7. Based on these findings, the substance was considered to be non-irritating to skin under the conditions of the study (Märtins T, 1988).