Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
data not available
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: 2c: Comparable to guideline study (OECD 404) with acceptable restrictions. The study was not GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: JO RF of 1971-04-21 and completed with JO RF of 1973-06-05
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(a) contact time (under an occlusive patch) was 23h instead of 4h. (b) 2 zones tested: the first one on previously scarified skin (right flank) and second one on intact zone (left flank). (c) observation at 24h and 72h instead of 1h, 24h, 48h, and 72h
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
no data

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.5 to 3.5 kg
- Housing: no data
- Diet (e.g. ad libitum): 200g per animal per day, classic granules (From Sanders)
- Water: ad libitum
- Other: rabbits were vaccinated before the test against pasteuriellosis and myxomatosis.
Animals were clipped with an electric clipper on a 12x12cm surface on both flanks. Precautions were taken to avoid any mecanical irritation of the zone to be tested. Only animals without any cutaneous lesion were selected for the tests.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+- 2°C
- Humidity: 55% +- 10%
- Air changes: 12 times per hour
- Photoperiod: 12h dark : 12h light


IN-LIFE DATES: data not available

Test system

Type of coverage:
occlusive
Preparation of test site:
other: one flank abraded and one flank intact
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount applied : 0.5g per zone tested (abraded or not) per animal
Duration of treatment / exposure:
23h
Observation period:
72h
Number of animals:
6 rabbits
Details on study design:
TEST SITE
- Area of exposure: 2 cm squared zone recovered by a sterile gauze pad. Material to be tested and the gauze pas are kept into contact with the skin by a patch consisting of a circular central disk of 22mm (occlusive patch) with a surrounding adhesive hypoallergenic, perforated plaster 10mm wide. Finally an adhesive tape 6cm wide is wound around the animal to complete the fixing of the patches.
- Type of wrap if used:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: the patches were removed after 23h of contact time. one hour after the scoring is evaluated.

SCORING SYSTEM is the same as in the OECD guideline:
erythematous lesions (and scar):
-no erythema......................................................0
- very slight erythema (barely perceptible)....1
- well defined reythema......................................2
- moderate to severe erythema........................3
- severe erythema, crimson red, with slight
eschar formation (injuries in depth)...............4

Oedematous lesions:
-no oedema.........................................................0
- very slight oedema (barely perceptible).......1
- slight oedema (edges of area well defined
by definite raising)..............................................2
- moderate oedema (area raised
approximatively 1 mm).....................................3
- severe oedema (raised more than 1 mm
and extending beyond area of application)....4

Afterwhat, calculations are slightly different: for each of the experimental animals, the scores after 24h and 72h are added together (scarified and non scarified zones). The scores are combined and divided by the number of readings (i.e. 24) to give a combined mean. the mean obtained is termed the index of primary cutaneous irritation and may be used to classify the test substance as follows:
- less than 0.5 ............. non irritant
- from 0.5 up to 2 .......slightly irritant
- from 2 up to 5 ..........moderatly irritant
- from 5 up to 8............severely irritant

As the evaluation is based on the same parameters and symptoms and the interpretations of the results are coherent, OECD calculations are used here.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 & 72hr
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 & 72h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No erythema or oedema were recorded in any of the six rabbits on the scarified and non scarified zones.
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
Under the conditions of this test, acid omega amino undecanoique is not irritating for the skin considering EU and GHS classification
Executive summary:

In a primary cutaneous irritation study (IFREB, 1978), six male albino New Zealand white rabbits were used. The six rabbits were clipped to bare a skin surface of 14 cm x 14 cm. The right flank was scarified, making three parallel superficial incisions which were epidermal and did not damage the dermis. The compound acide omega amino undecanoique (0.5 g) was applied to the rabbit skin, using the right, previously scarified flank and the left intact one under an occlusive coverage. After 23 hours of contact with the skin, the primary irritation index was evaluated at 24 and 72 hr. No erythema or oedema were recorded in any of the six rabbits on the scarified and non scarified zones. The scores obtained were 0 for erythema and oedema at 24 and 72 hr. Under the conditions of this test, the substance is not irritant according to EU and GHS classification.