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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
31 May 1988 - 4 June 1988.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
To address toxicological endpoints as part of the REACH registration of Cyclamen Aldehyde Extra (Target substance) It is proposed to read across to Florhydral (Source substance) The use of read-across works within the spirit of REACH and the stated aim of the legislation to reduce animal testing where possible. The Target Substance and Source Substance have been characterised in using the categories and databases present in the OECD QSAR toolbox . From the profiling in this table , it can be seen that the two substances share structural similarities and also ‘mechanistic action’ similarities which are both general and endpoint specific. Therefore read across is justified.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
The hair was clipped from the dorsal area of the trunk of each rabbit approximately 24 h before treatment. Care was taken to avoid abrading the skin.
The test material (0.5 ml) was applied to intact skin on each rabbit under a 2.5 cm x 2.5 cm patch of gauze. The patch was then covered with Micropore tape and the trunk was loosely bound with Elastoplast Elastic Bandage which remained in position for 4 h. At the end of this period the patches were removed and the skin wiped with water dampened tissues to remove surplus test material without altering the existing response or the integrity of the epidermis.
Skin reactions were assessed 1, 24, 48 and 72 h after patch removal.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Florhydral
- IUPAC name: β-methyl-3-(1-methylethyl)benzenepropanal
- CAS number: 125109-85-5
- EC number: 412-050-4
- Molecular formula (if other than submission substance): C13H18O
- Molecular weight (if other than submission substance): 190
- Smiles notation (if other than submission substance): CC(C)C1=CC(=CC=C1)C(C)CC=O
- InChl (if other than submission substance):
InChI: InChI=1S/C13H18O/c1-10(2)12-5-4-6-13(9-12)11(3)7-8-14/h4-6,8-11H,7H2,1-3H3
InChI key: InChIKey=OHRBQTOZYGEWCJ-UHFFFAOYSA-N
- Structure: image attached below
- Substance type: Fragrance ingredient
- Physical state: colourless liquid
- Lot/batch No.: 8906-87

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Two male and one female (nulliparous and non-pregnant) young adult New Zealand White rabbits were used. They were supplied by Cheshire Rabbit Farms Limited, Duddon Lodge, Tarporley, Cheshire and arrived at Elphinstone Research Centre on 24 May 1988.
The rabbits were housed individually in aluminium cages with grid floors beneath which were peat moss filled trays. The rabbits were fed Rabbit Diet, supplied by Special Diet Services (1 Stepfield, Hitham, Essex, CM8 3AB), and allowed food and tap water ad libitum. The diet and water are analysed on a regular basis and
meet the criteria laid down by IRI.
Mean environmental maximum and minimum temperatures were 19°C and 17°C and mean relative humidity was 58%. A 12 h light/dark cycle was in operation (light hours 0700-1900 h).
The rabbits were allowed an acclimatisation period of 7 days before test commencement. The rabbits were uniquely identified within the study by means of an
indelible number on the inner surface of the ear.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
The test material (0.5 ml) was applied to intact skin on each rabbit
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
Method
The hair was clipped from the dorsal area of the trunk of each rabbit approximately 24 h before treatment. Care was taken to avoid abrading the skin.
The test material (0.5 ml) was applied to intact skin on each rabbit under a 2.5 cm x 2.5 cm patch of gauze. The patch was then covered with Micropore tape and the trunk was loosely bound with Elastoplast Elastic Bandage which remained in position for 4 h. At the end of this period the patches were removed and the skin wiped with water dampened tissues to remove surplus test material without altering the existing response or the integrity of the epidermis.
Skin reactions were assessed 1, 24, 48 and 72 h after patch removal using the scoring system as detailed below:

OECD Recommended Scoring System
Erythema and Eschar Formation Grade
No erythema . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . .0
Very slight erythema (barely perceptible) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
Well defined erythema . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Moderate to severe erythema . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) . . . .4

Oedema Formation
No oedema . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .0
Very slight oedema (barely perceptible) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Slight oedema (edges of area well defined by definite raising) . . . . . . . . . . . . . . . . . . . . . . . . 2
Moderate oedema (area raised approximately 1 mm) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
Severe oedema (raised by more than 1 mm and extending beyond area of exposure) . . . 4

Results and discussion

In vivo

Results
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
1
Irritant / corrosive response data:
RESULTS
Details of individual reaction scores are given in the Table below. Well defined erythema was noted at 2 treated sites at 1 h after patch removal only. Very slight erythema was noted at all treated sites at 24 h and on 2/3 treated sites at 48 h after patch removal. No oedema was noted and all treated sites had returned to normal at 72 h. Slight dryness was noted on one test site at 72 h.

Any other information on results incl. tables

Reaction Scores

Animal / Sex Erythema Oedema
1h 24h 48h 72h 1h 24h 48h 72h
1 ♂ 1 1 1 0 0 0 0 0
2 ♀ 2 1 0 0 0 0 0 0
3 ♂ 2 1 1 0* 0 0 0 0

* = slight dryness

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
GIV 82-4130 is slightly irritating to rabbit skin
Executive summary:

Well defined erythema was noted at 2 treated sites at 1 h after patch removal only. Very slight erythema was noted at all treated sites at 24 h and on 2/3 treated sites at 48 h after patch removal. No oedema was noted and all treated sites had returned to normal at 72 h. Slight dryness was noted on one test site at 72 h.

GIV 82-4130 was concluded to be slightly irritating to rabbit skin