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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:
weight of evidence
Study period:
1986-02-25 to 1986-03-04
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Meets generally accepted scientific standards, well documented and acceptable for assessment.

Data source

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

Materials and methods

Principles of method if other than guideline:
Test material applied semiocclusively to the skin of 4 rabbits for 4 hrs, at concentrations of 100% and 50 %. Skin reactions were reacorded after 1 hour, 24, 48, 72 hours and 7 days.
GLP compliance:
yes
Remarks:
no certificate

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Cyclamen aldehyde
- Substance type: No data
- Physical state: No data
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No: No data
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: Refridgerated at 4 °C
- Other: Delivery date 1986-02-14

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: A Smith, Warlingham, Surrey, United Kingdom
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: Individually in anodised aluminium cages with grid floors and no bedding
- Diet: Ad libitum, rabbit pellets (680, Dalgety-Spillers Ltd)
- Water: Mains tap water, ad libitum.
- Acclimation period: ≥ 5 d.

ENVIRONMENTAL CONDITIONS
- Temperature: 18 °C to 24 °C
- Humidity: 40 % - 67 %
- Air changes per hr: No data
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: 100 % solution - no vehicle. 50 % solution DEP
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Volume applied: 0.5 mL:
- Concentration of test substance: 100 %, 50 % in DEP
Duration of treatment / exposure:
4 hrs
Observation period:
7 d (observations at 1 hr, 24 hrs, 48 hrs, 72 hrs and 7 d after removal of test material)
Number of animals:
4 (each animal treated with both concentrations)
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm²
- Type of wrap if used: Elastoplast elastic adhesive barrier, 10 cm width.

REMOVAL OF TEST SUBSTANCE
- Washing: Adhesive tapes removed, gentle swabbing with cotton wool soaked in warm water
- Time after start of exposure: 4 hrs

SCORING SYSTEM:
- Erythema and eschar formation:
-- 0: No erythema
-- 1: Very slighty erythema (barely perceptible)
-- 2: Well-defined erythema
-- 3: Moderate to severe erythema
-- 4: Severe erythema (beet redness) to slight eschar formation (injuries in depth)
- Oedema formation:
-- 0: No oedema
-- 1: Very slight oedema (barely perceptible)
-- 2: Slight oedema (edges of area well defined by definite raising)
-- 3: Moderate oedema (raised approximately 1 mm)
-- 4: Severe oedema (raised more than 1 mm and extending beyond area of exposure)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Reversibility:
not fully reversible within: 7 d.
Remarks on result:
other: 50% solution. Desquamation at 7 d.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: 50% solution. Marked desquamation at 7d.
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Reversibility:
not fully reversible within: 7 d
Remarks on result:
other: 50% solution. Marked desquamation at 7 d.
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2.67
Reversibility:
not fully reversible within: 7 d
Remarks on result:
other: 50% solution. Marked desquamation at 7 d.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.67
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: 50% solution
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: 50% solution
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.33
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: 50% solution
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
3
Reversibility:
not fully reversible within: 7 d
Remarks on result:
other: 50% solution
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Reversibility:
not fully reversible within: 7 d
Remarks on result:
other: 100% solution. Marked desquamation at 7 d.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Reversibility:
not fully reversible within: 7 d
Remarks on result:
other: 100% solution. Marked desquamation at 7 d.
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Reversibility:
not fully reversible within: 7 d
Remarks on result:
other: 100% solution. Marked desquamation at 7 d.
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2.67
Reversibility:
not fully reversible within: 7 d.
Remarks on result:
other: 100% solution. Marked desquamation at 7 d.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.67
Reversibility:
not fully reversible within: 7 d.
Remarks on result:
other: 100% solution
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.67
Reversibility:
not fully reversible within: 7 d
Remarks on result:
other: 100% solution
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.33
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: 100% solution
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
3
Reversibility:
not fully reversible within: 7 d
Remarks on result:
other: 100% solution
Irritation parameter:
erythema score
Basis:
mean
Remarks:
Of all animals
Time point:
24/48/72 h
Score:
2.2
Remarks on result:
other: 100% solution
Irritation parameter:
edema score
Basis:
mean
Remarks:
Of all animals
Time point:
24/48/72 h
Score:
2.67
Remarks on result:
other: 100% solution
Other effects:
Marked desquamation in rabbits 920, 922 and 923 at 7 d; desquamation in rabbit 916 at 7 d; no other comments.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant)
Conclusions:
Two concentrations of cyclamen aldehyde were tested. Classification is based on the study performed with 100%. The study was performed with more than 3 animals. In this case specific provisions apply to the classification criteria in CLP Regulation (EC) no. 1272/2008. In accordance with this classification criteria the test substance is considered to be a Category 2 skin irritant.