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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:
Between 7 and 17 December 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to Annex VI directive 92/69/EEC Part B Method B.4 and under GLP Guidelines.
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Hexyl Cinnamic Aldehyde
- Storage condition of test material: room temperature in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 12 to 14 weeks old
- Weight at study initiation: 2.8 to 3.2 Kg
- Housing: housed individually in metal cages with perforated floors.
- Diet (e.g. ad libitum): standard laboratory diet SDS Stanrab (P) Rabbit Diet provided ad libitum
- Water (e.g. ad libitum): provided ad libitum
- Acclimation period: no information


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 ºC
- Humidity (%): 30-70%
- Air changes (per hr): 19 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light in each 24 hours period

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):0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
11 days
Number of animals:
3 rabbits
Details on study design:
TEST SITE
- Area of exposure: 100 mm X 100 mm
- Type of wrap if used: "Elastoplast" elastic adhesive dressing


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water (30 ºC to 40 ºC)
- Time after start of exposure: 4 hours. The treated area was blotted dry with absorbent paper


SCORING SYSTEM:
Erythema and eschar formation
No erythema: 0
Very slight erythema: 1
Well-defined erythema: 2
Moderate to severe erythema: 3
Severe erythema to slight eschar formation: 4

Oedema formation
No oedema: 0
Very slight oedema: 1
Slight oedema: 2
Moderate oedema: 3
Severe oedema: 4

Any other lesion not covered by this scoring system, was described.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean individual score
Time point:
other: overall 24-48-72h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 11 days
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean individual score
Time point:
other: overall 24-48-72h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 11 days
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean individual score
Time point:
other: overall 24-48-72h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean individual score
Time point:
other: overall 24-48-72h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 11 days
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean individual score
Time point:
other: overall 24-48-72h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 11 days
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean individual score
Time point:
other: overall 24-48-72h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 11 days
Irritant / corrosive response data:
See Table 7.3.1/1
Other effects:
There were no signs of toxicity or ill health in any rabbit during the observation period

Any other information on results incl. tables

Table 7.3.1/1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Rabbit number and sex

E = Erythema O = Oedema

Day
1 2 3 4 5 6 7 8 9 10 11
2791 male E 2 2 2 2 a3 a3 a2 a1 a1 a1 0
O 1 1 2 2 2 2 2 1 1 1 0
2792 male E 2 2 2 2 a2 a2 a1 a1 a1 a1 0
O 1 2 2 1 1 1 1 1 1 1 0
2793 male E 2 2 2 2 2 a2 a0 a0 a0 a0 0
O 1 2 2 2 1 1 1 1 1 1 0
a Desquamation of the stratum corneum

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information R38 Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions HCA is classified as irritating to skin (Xi; R38) according to the Directive 67/548/EEC but is not classified under the Regulation (EC) No. 1272/2008 (CLP).
Executive summary:

In a dermal irritation study performed according to the EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion) and in compliance with GLP, 3 male New Zealand White rabbits, were exposed to 0.5 mL of undiluted Hexyl cinnamic aldehyde (HCA). Test sites were covered with a semi-occlusive dressing for 4 hours. Animals were then observed for 11 days. 

The mean individual scores calculated within 3 scoring times (24, 48 and 72 hrs) were 2/2/2 for erythema and 1.33/1.67/1.67 for edema. All the reactions were fully reversible within 11 days.

 

Under the test conditions HCA is classified as irritating to skin (Xi; R38) according to the Directive 67/548/EEC but is not classified under the Regulation (EC) No. 1272/2008 (CLP).

 

This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.