Registration Dossier

Administrative data

Description of key information

Irritation/ corrosion:
skin: not irritating for rabbit (similar to OECD TG 404)
eye: slightly irritating for rabbit (similar to OECD TG 405)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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.
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
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
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.
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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye 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 with acceptable restrictions. No GLP study.
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 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.5 kg
- Housing: no data
- Diet: 200g per animal per day, classic granules (from Sanders)
- Water ad libitum
- Other: rabbits were vaccinated before the test against pasteurellosis and myxomatosis
Only animals with normal eye conditions were selected for the test, any with ocular lesion were rejected.

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

IN-LIFE DATES: no data
Vehicle:
unchanged (no vehicle)
Controls:
other: left eye
Amount / concentration applied:
- Amount applied: 100 mg per rabbit
- substance instilled in the right eye (left eye = control)
Duration of treatment / exposure:
7 days
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
no washing was done
observations of the conditions of the cornea were done with the naked eye with an ophtalmoscop of Heine (Microflex C-00. 13. 101)

SCORING SYSTEM:
the scoring is based on the same parameter and symptoms as in the OECD guideline : cornea, conjunctive, iris and chemosis.
Other parameters were observed in this study like discharge, ulceration and granulation of the cornea.
Then the calculation for the interpretation of the results is slightly different in that the scores are added and a coefficient is applied : 2 for conjunctive and chemosis parameter and 5 for iris anc cornea scores.
As the evaluation is based on the same parameters and symptoms and the interpretations of the results are coherent, OECD calculations are used here.

TOOL USED TO ASSESS SCORE: hand-slit lamp or ophtalmoscop of Heine.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72h
Score:
0.16
Max. score:
4
Reversibility:
fully reversible within: 2d
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, and 72h
Score:
0.27
Max. score:
3
Reversibility:
fully reversible within: 3d
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, and 72h
Score:
0.11
Max. score:
2
Reversibility:
fully reversible within: 3d
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, and 72h
Score:
0
Max. score:
4
Irritant / corrosive response data:
for raw data and scoring according to OECD guideline see table 1 in the "remarks on results" freetext
Other effects:
Only a slight discharge was observed 1h after instillation in the six rabbits. After 1 day no more discharge was observed in all the rabbits.

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

Score at time point/ Reversibility  Cornea
Max. score: 4
Iris
Max. score: 2
Conjunctivae
Max. score: 3
Chemosis
Max. score: 4
60 min 0/0/0/0/0/0 1/1/1/1/1/1 1/1/1/1/1/1 2/1/1/2/2/2
24 h 0/0/0/0/0/0 0/0/0/0/1/0 0/1/0/0/1/1 1/0/0/0/1/1
48 h 0/0/0/0/0/0 1/0/0/0/0/0 1/0/0/1/0/0 0/0/0/0/0/0
72 h 0/0/0/0/0/0 0/0/0/0/0/0 0/0/0/0/0/0 0/0/0/0/0/0
Average 24h, 48h, 72h 0 0.11 0.27 0.16
Reversibility*) - c. c. c.
*) Reversibility: c.=completely reversible; n.c.= not completely reversible; n= not reversible

After 72h the animals were kept under observation but animals kept with normal eyes. The reversibility was complete.

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

In an ocular irritation test (IFREB, 1978), six male albino New Zealand white rabbits were used. The test substance (acide omega amino undecanoique) was introduced into the animal's right eye, the animal's left eye served as a control. Animals were observed for 7 days. Irritation was scored following a grading of ocular lesions similar to that of the guideline OECD 405. The results showed that the substance was slightly irritating. After one hour the 6 rabbits showed chaemosis, discharge, enanthema and congestion reactions. Most of these effects decreased after 24 hr and desappeared totally after 3 days.The scores (mean: 24, 48 and 72 hr scores) obtained for chemosis, redness of conjunctivae, iris lesion and cornea opacity were respectively 0.26, 0.27, 0.11 and 0. Under the conditions of this test, the substance is considered as not irritating according to EU and GHS classification.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation/corrosion:

One study is recorded for this endpoint. This study has been identified as suitable to be chosen as key study. Indeed, this study was performed with New Zealand White rabbits following a method comparable to OECD TG 404 with acceptable restrictions. Results showed that 11 -aminoundecanoic acid is not irritant after a 24 -hour occlusive application on the abraded or intact rabbit skin.

Eye irritation:

Two studies are recorded for this endpoint. One is an in vivo ocular irritation test (IFREB, 1978) which has been chosen as key study. The second is a publication using an in vitro EYTEX system for the ocular irritancy of chemical products (Régnier et al., 1994) which has been chosen as supporting study. The in vivo test showed chaemosis, discharge, enanthema and iris congestion as soon as 1 -hour after application of the substance in 6 rabbits. But after 72 -hours all these effects had desappeared. In the in vitro experiment, based on alterations in a protein matrix, 11 -aminoundecanoic acid was also classified as non-irritant. All together, these results showed that 11 -aminoundecanoic acid is not an eye irritant.

Conclusion:

Under the conditions of these tests, 11-aminoundecanoic acid induced no skin irritation and only a slight transient eye irritation in rabbits.


Effects on eye irritation: slightly irritating

Justification for classification or non-classification

Accordingt to REGULATION (EC) no 1272 -2008:

  • Skin irritation/ corrosion: not classified, mean scoring value for erythema/eschar or for oedema was 0.
  • Eye irritation/ corrosion: not classified, mean scoring value for corneal opacity or iritis was beneath 1 and conjunctival redness or conjunctival oedema was beneath 2. Moreover, the observed slight irritation was fully reversible within 21 days.