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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
Available In vivo studies were sufficient to allow us to filled this endpoint and determined the classification.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 17, 1985 - December 30, 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
The study has been performed equivalent to OECD 404 guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
other: EEC Directive 79-831, Annex V, Part B: Methods for the determination of toxicity, B.4. Acute toxicity, skin irritation, dated December 1983.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-butyl-3,6-dihydro-4,6-dimethyl-2H-pyran
EC Number:
246-099-6
EC Name:
2-butyl-3,6-dihydro-4,6-dimethyl-2H-pyran
Cas Number:
24237-01-2
Molecular formula:
C11H20O
IUPAC Name:
2-butyl-4,6-dimethyl-3,6-dihydro-2H-pyran
Constituent 2
Chemical structure
Reference substance name:
6-butyl-3,6-dihydro-2,4-dimethyl-2H-pyran
EC Number:
246-098-0
EC Name:
6-butyl-3,6-dihydro-2,4-dimethyl-2H-pyran
Cas Number:
24237-00-1
Molecular formula:
C11H20O
IUPAC Name:
6-butyl-2,4-dimethyl-3,6-dihydro-2H-pyran
Constituent 3
Chemical structure
Reference substance name:
2-butyltetrahydro-6-methyl-4-methylene-2H-pyran
EC Number:
246-101-5
EC Name:
2-butyltetrahydro-6-methyl-4-methylene-2H-pyran
Cas Number:
24237-02-3
Molecular formula:
C11H20O
IUPAC Name:
2-butyl-6-methyl-4-methylenetetrahydro-2H-pyran
Specific details on test material used for the study:
Material Identification (as stated in the report) : Gyrane ST 2
Appearance: Clear yellow slightly viscous liquid
Sample received on: November 25, 1985

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: ENKI-Konijnenfarm, Someren, The Netherlands
- Weight at study initiation: 2500 - 3500 g
- Housing: Individually in suspended, galvanized cages, fitted with wire-mesh floor and front.
- Diet and water: provided ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 40 - 70
- Air changes (per hr): approximately 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
The skin reactions were assessed directly, 24, 48 and 72 hours and 7 and 13 days after the removal of the dressings and test substance.
Number of animals:
6 male adults
Details on study design:
STUDY DESIGN
The test substance is brought on the intact and abraded skin under a surgical patch measuring 1 inch x 1 inch. The patch were fixed to the application site by means of adhesive tape and the entire trunk of each rabbit was wrapped with an impervious material to maintain the test patches in position and to retard the evaporation of the test material.

TEST SITE
Twenty four hours prior to applying the material, the hair is removed from the back and flanks of the animals with an electric clipper in such a way as to avoid abrasions.
Six rabbits are treated on the intact skin and on the abraded skin. The abrasions are minor incisions of the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding.

REMOVAL OF TEST SUBSTANCE
Four hours after the application, the dressing and test substance was removed.

SCORING SYSTEM:
The irritation was assessed according to the numerical scoring system according to OECD 404.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 3452 and 3455
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 13 days
Irritation parameter:
erythema score
Basis:
animal: 3453 and 3454
Time point:
24/48/72 h
Score:
1.6
Max. score:
2
Reversibility:
fully reversible within: 13 days
Irritation parameter:
erythema score
Basis:
animal: 3456 and 3457
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 13 days
Irritation parameter:
edema score
Basis:
animal: 3452, 3453, 3454, 3456 and 3457
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 13 days
Irritation parameter:
edema score
Basis:
animal: 3455
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
After 4 to 76 hours after exposure, the dermal effects observed in all six animals consisted of very slight or well-defined erythema with or without very slight oedema. After seven days, very slight erythema with or without very slight oedema was observed in five out of six animals. There were no significant differences between the effects of the intact skin and the effects of the abraded skin. After 13 days, all skin effects had cleared completely.

Applicant's summary and conclusion

Interpretation of results:
Category 3 (mild irritant) based on GHS criteria
Conclusions:
In an skin irritation study with rabbits, performed equivalent to OECD 404 test guidelines and GLP principles, slight irritation was observed but no sufficient to classify according the CLP Regulation (EC) No. 1272/2008.
Executive summary:

Gyrane St 2 was tested in a skin irritation study with rabbits, performed equivalent to OECD 404 test guideline and GLP principles.

After 4 to 76 hours after exposure, the dermal effects observed in all six animals consisted of very slight or well-defined erythema with or without very slight oedema. After seven days, very slight erythema with or without very slight oedema was observed in five out of six animals. There were no significant differences between the effects of the intact skin and the effects of the abraded skin. After 13 days, all skin effects had cleared completely.

Based on the results, slight irritation was observed but no sufficient to classify according the CLP Regulation (EC) No. 1272/2008.