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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:
1979-10-22 to 1979-11-05
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted similarly to OECD Guideline 404 with deviations: no data about purity and no certificate of analysis of the test substance; occlusive patches were applied for 24 h and skin reactions were scored at 24 and 72 h after application; observations not followed until the reversibility of the effects
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:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
no data about purity and no certificate of analysis of the test substance; occlusive patches were applied for 24 h and skin reactions were scored at 24 and 72 h after application; observations not followed until the reversibility of the effects
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Type:
impurity
Type:
impurity
Test material form:
liquid
Details on test material:
Main component of the mixture comprises of two isomers: rel-(3R,4S)-tetrahydro-3-pentyl-2H-pyran-4-yl acetate and rel-(3R,4R)-tetrahydro-3-pentyl-2H-pyran-4-yl acetate.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
- Source: Suitably licensed dealer
- Age at study initiation: 3 months
- Weight at study initiation: Approximately 2 kg
- Housing: Housed in galvanized or stainless steel cages.
- Diet (e.g. ad libitum): Growth and maintenance ration from a commercial producer; ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: Controlled
- Photoperiod: 12 h light / 12 h dark

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped (intact) or abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
Six
Details on study design:
- Area of exposure: Mid-dorsal area of the trunk, between the scapulae and the pelvis
- % coverage: Two test sites (2 cm2) were chosen on opposite sides of the vertebral column. The test site on the left side of the animal remained intact; the test site on the right was further prepared by abrading with a sterile 22 gauge hypodermic needle. Test substance (0.5 mL) was applied under surgical gauze (5 cm2) to the intact and abraded skin sites on each animal and the gauze was held in place with an adhesive tape.
- Type of wrap used: After both test sites were treated, the entire trunk of each animal was encased in an impermeable occlusive wrapping fixed in place with adhesive tape.

REMOVAL OF TEST SUBSTANCE
- After an exposure period of 24 h, the patches and the applied material were removed. Remaining test article was gently wiped from the skin.

SCORING SYSTEM:
- Skin reactions were scored at 24 and 72 h after application according to Draize scoring system (1975)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: average of 24 and 72 h
Score:
0.8
Max. score:
4
Reversibility:
no data
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: average of 24 and 72 h
Score:
0.1
Max. score:
4
Reversibility:
no data
Remarks on result:
other: intact skin
Irritant / corrosive response data:
See table 7.3.1/1
Other effects:
None

Any other information on results incl. tables

Table 7.3.1/1: Skin irritation data for individual rabbits

Rabbit number

Irritation scores (Intact skin)

24 h

72 h

Mean (24 and 72 h)

Erythema

Oedema

Erythema

Oedema

Erythema

Oedema

1

1

0

1

0

1.0

0.0

2

1

1

1

0

1.0

0.5

3

1

0

0

0

0.5

0.0

4

1

0

0

0

0.5

0.0

5

1

0

0

0

0.5

0.0

6

1

0

1

0

1.0

0.0

Mean (all 6 animals)

0.8

0.1

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under these test conditions, Jasmopyrane Forte is not classified as irritating to skin according to the Directive 67/548/EEC and the CLP Regulation.
Executive summary:

In a primary dermal irritation study performed similarly to OECD Guideline 404, 0.5 mL of Jasmopyrane Forte was applied, under an occlusive patch (5 cm2), to intact and abraded skin sites on opposite sides of the vertebral column of six New Zealand White rabbits. After an exposure period of 24 h, the patches and the applied material were removed and skin reactions were scored by Draize method. A second reading was recorded 48 h later (72 h after application). Irritation scores at 48 h after application were derived using the worst case scores recorded at 24 or 72 h.

The calculated mean scores for each individual lesion for all animals within three scoring times (24 h and 72 h) were as follows: 0.8 for erythema score (intact skin) and 0.1 for oedema score (intact skin).

Under these test conditions, Jasmopyrane Forte is not classified as irritating to skin according to the Directive 67/548/EEC and the CLP Regulation.