Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
QUALITY ASSURANCE ATTESTATION, G.L.P. COMPLIANCE STATEMENT & GLP certificates included in the full report. The study was conducted according to an internationally recognised method, and under GLP. No deviation was reported. The substance is adequately characterised. Therefore full validation applies.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
test method B.4 of the directive 2004/73/EC
Deviations:
yes
Remarks:
Environmental parameters: A relative humidity of 19 % was registered instead of 30 % (minimal limit) as planned in the experimental protocol. A temperature of 24°C was registered instead of 23°C (maximal limit) as planned in the experimental protocol.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
6,8-dimethylnon-7-enal
EC Number:
486-670-9
Cas Number:
899810-84-5
Molecular formula:
C11H20O
IUPAC Name:
6,8-dimethylnon-7-enal
Test material form:
other: liquid
Details on test material:
• Form : liquid
• Colour : colorless
• Batch n° : 862036
• Storage : room temperature
• Production date: September 2007 • Expiry date: September 2008
• Purity/Concentration: 97.79%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Three male albino New Zealand rabbits were supplied by the Elevage de Gérome (Quartier Labaste –
F40260 Linxe). They were kept during a minimal 5-day acclimatisation period. During the test, the
animals weighed between 2.54 kg and 3.33 kg. At the beginning of the test, the animals were 12 to 13-
week old.
Each animal was kept in an individual box installed in conventional air conditioned animal
husbanding; the environmental conditions were:
- temperature : between 18°C and 24°C
- relative humidity : between 19% and 70%
- lighting time: 12 hours daily

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
The test item was applied, as supplied, at a dose of 0.5 mL,
Duration of treatment / exposure:
72 h
Observation period:
The skin reactions were appreciated 1 hour and then 24, 48 and 72 hours after removal of the patch.
Number of animals:
3 males
Details on study design:
Approximately 24 hours before the test, the rabbits’ backs and flanks were shorn using electric
clippers equipped with a fine comb, so as to expose an area of skin about 6 cm2.
The test item was applied, as supplied, at a dose of 0.5 mL, on an undamaged skin area of one flank of
each animal, during 4 hours. The patch was secured in position with a strip of surgical adhesive tape.
After the removal of the patch, the treated area was rinsed with distilled water.
On the opposite flank an untreated area was served as the control.
Initially, a single animal was treated. After consideration of the cutaneous responses produced in the
first treated animal, two additional animals were treated.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
ca. 2
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
ca. 2
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
ca. 2
Irritation parameter:
erythema score
Max. score:
2
Remarks on result:
other: Max. duration: 72 d; Max. value at end of observation period: CA 2 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
ca. 2
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
ca. 1.7
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
ca. 1.7
Irritation parameter:
edema score
Max. score:
2
Remarks on result:
other: Max. duration: 72 d; Max. value at end of observation period: CA 2 (related to all animals)
Irritant / corrosive response data:
It was noted, 1 hour after the test item application, on the treated area, a well defined erythema
associated with a slight oedema.
On the cutaneous structure, a dryness was noted on the treated area, from D3 in two animals and from
D6 in the last one.
Other effects:
The oedematous reactions were totally reversible at D6 and the
erythematous reactions were totally reversible between D6 and D8.
The skin recovered a normal aspect between D9 and D10 in two animals but a
slight dryness was still registered the last day of the test (D14) in one animal.

La scheresse de la peau n'est pas rversible aprs 14 jours
pour un animal sur trois, elle est rversible pourles deux
autres entre 9 10 jours.

Any other information on results incl. tables

The individual and mean scores obtained during the study are given in the attached full report.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The results obtained, under these experimental conditions, enable to conclude that the test item
according to the scales of interpretation retained:
- is irritant to skin (PSi = 3.7) according to the classification established in the Journal Officiel de la
République Française dated February 21st, 1982,
- and, needs to be classified “irritant to skin”, according to the EU criteria for classification,
packaging and labelling of dangerous substances and preparations.
Executive summary:

The test item was applied, as supplied, at the dose of 0.5 mL, under semiocclusive

dressing during 4 hours on an undamaged skin area of three rabbits. The experimental

protocol was established from the O.E.C.D. guideline n° 404 dated April 24th, 2002 and the test

method B.4 of the directive n° 2004/73/EC.

It was noted, 1 hour after the test item application, on the treated area, a well defined erythema

associated with a slight oedema. The oedematous reactions were totally reversible at D6 and the

erythematous reactions were totally reversible between D6 and D8.

On the cutaneous structure, a dryness was noted on the treated area, from D3 in two animals and from

D6 in the last one. The skin recovered a normal aspect between D9 and D10 in two animals but a

slight dryness was still registered the last day of the test (D14) in one animal.

The results obtained, under these experimental conditions, enable to conclude that the test item

needs to be classified R38 “irritant to skin”, according to the criteria for

classification, packaging and labelling of dangerous substances and preparations in compliance with

the E.E.C. Directives 67/548, 2001/59 and 99/45. The test item must be characterised by the symbol

“Xi” and the warning label “irritant”.