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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:
1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study to GLP for which a study report is available

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

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

Test material

Constituent 1
Reference substance name:
9004-77-7
Cas Number:
9004-77-7
IUPAC Name:
9004-77-7
Constituent 2
Chemical structure
Reference substance name:
Poly(oxy-1,2-ethanediyl), α-butyl-ω-hydroxy-
EC Number:
500-012-0
EC Name:
Poly(oxy-1,2-ethanediyl), α-butyl-ω-hydroxy-
Cas Number:
9004-77-7
Molecular formula:
(C2H4O)nC4H10O
IUPAC Name:
Poly(oxy-1,2-ethanediyl), α-butyl-ω-hydroxy-
Constituent 3
Reference substance name:
Poly(oxy-1,2-ethanediyl), α-butyl-ω-hydroxy
IUPAC Name:
Poly(oxy-1,2-ethanediyl), α-butyl-ω-hydroxy
Details on test material:
- Name of test material (as cited in study report): DCP 208
- Physical state: brown liquid
- Lot/batch No.: BP DCP208/HPC/June 93
- Storage condition of test material: Room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Animals were given a unique number within the study which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label.

TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: 12-16 weeks old
- Weight at study initiation: 2.32 – 2.48 kg
- Housing: Animals were housed individually in suspended metal cages
- Diet: RABMA Rabbit Diet, Special Diet Services Ltd., Witham, Essex, U.K. ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19 – 23°C
- Humidity: 62-67%
- Air changes: 15 changes/hr
- Photoperiod: 12 hours light/12 hours dark

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml of the test material was introduced under a 2.5 cm x 2.5 cm gauze patch and placed in position on the shorn skin.
Duration of treatment / exposure:
4 hours
Observation period:
Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the scale from Draize J.H. (1959) Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs
and Cosmetics"
Number of animals:
3 (one female, two male)
Details on study design:
TEST SITE
- Area of exposure: dorsal flank
- Type of wrap if used: BLENDERM: approximate size 2.5 cm x 4.0cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize J.H. (1959) Association of Food and Drug Officials of the United States, Austin, Texas, “The Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics”

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Score:
0.2
Max. score:
8
Remarks on result:
other: 1/6 rabbits showed any response
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.22
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: mean for all animals
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects seen
Remarks on result:
other: mean for all animals
Irritant / corrosive response data:
Very slight erythema was noted at two treated skin sites one hour after patch removal and at one treated skin site at the 24 and 48-hour observations.

No skin reactions were noted 72 hours after treatment.
Other effects:
No further details available.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material, Poly(oxy-1,2,-ethanediyl), α-butyl, ω-hydroxyl, produced a primary irritation index of 0.2 and was classified as a MILD IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

The test material did not produce positive criteria in any rabbit according to the EEC labeling regulations and was classified as NON-IRRITANT to rabbit skin. No symbol and risk phrase are therefore required.
Executive summary:

In a guideline (OECD 404) and GLP skin irritancy study, a substance meeting the description Poly(oxy-1,2,-ethanediyl), α-butyl, ω-hydroxyl was found to be a mild irritant to rabbit skin (PDII = 0.2) with all effects (mild erythema but no odema) fully reversible within 72 hours.