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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 21 January 2013 to 04 February 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: A well documented GLP study according to OECD guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Undecanedioic acid
EC Number:
217-440-6
EC Name:
Undecanedioic acid
Cas Number:
1852-04-6
Molecular formula:
C11H20O4
IUPAC Name:
undecanedioic acid
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): UNDECANEDIOIC ACID
- Physical state: white powder
- Analytical purity: 97.0 %
- Purity test date: 2012-05-09
- Lot/batch No.: 1112050079
- Expiration date of the lot/batch: 07 June 2015
- Storage condition of test material: room temperature

Test animals / tissue source

Species:
rabbit
Strain:
other: albino New Zealand rabbit
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: the Elevage de Gérome (Quartier Labaste – F40260 Linxe)
- Age at study initiation: 13-14 weeks old
- Weight: between 2.17 kg and 3.13 kg
- Housing: the animal was kept in an individual box installed in conventional air conditioned animal husbanding
- Diet: foodstuff (SAFE – 112)
- Water: tap-water from public distribution system
- Acclimation period: minimal 5-day acclimatisation period

ENVIRONMENTAL CONDITIONS
- Temperature: 17 to 23 °C
- Humidity: 30 to 70 %
- Air changes: between 10 and 15 changes per hour
- Photoperiod: the lighting was controlled by a time switch to give twelve hours continuous light (07.00 to 19.00) and twelve hours darkness.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The other eye remained untreated serving as control.
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 g
Observation period (in vivo):
Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following treatment.
Number of animals or in vitro replicates:
3 animals.
Initially, a single animal was treated. After consideration of the responses produced on day 7 in the first animal, two additional animals were treated.
Details on study design:
0.1 g of the test item was instilled, as supplied, into the conjunctival sac of one eye after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the test item. The other eye remained untreated serving as control.
Initially, a single animal was treated. After consideration of the responses produced on day 21 in the first animal, two additional animals were not treated.
Remaining test item requiring physiological rinse was noted, one hour after the test item instillation, in two animals.

If no reaction is observed 72 hours after instillation, the study is terminated. In case of persistent reactions, additional observations can be carried out from D7 to D21 in order to determine the reversible character of the lesions observed.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48 and 72h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48 and 72h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48 and 72h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
- redness
Basis:
animal #1
Time point:
other: 24, 48 and 72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
- redness
Basis:
animal #2
Time point:
other: 24, 48 and 72h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
- redness
Basis:
animal #3
Time point:
other: 24, 48 and 72h
Score:
2.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Remarks:
- lesion
Basis:
animal #1
Time point:
other: 24, 48 and 72h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 3 days
Irritation parameter:
iris score
Remarks:
- lesion
Basis:
animal #2
Time point:
other: 24, 48 and 72h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 3 days
Irritation parameter:
iris score
Remarks:
- lesion
Basis:
animal #3
Time point:
other: 24, 48 and 72h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 3 days
Irritation parameter:
cornea opacity score
Remarks:
- opacity
Basis:
animal #1
Time point:
other: 24, 48 and 72h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Remarks:
- opacity
Basis:
animal #2
Time point:
other: 24, 48 and 72h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Remarks:
- opacity
Basis:
animal #3
Time point:
other: 24, 48 and 72h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
The ocular reactions observed during the study have been moderate to important and totally reversible:
- at the conjunctivae level: a moderate to important redness noted 1 hour after the test item instillation and totally reversible on day 7, associated with a moderate to important chemosis noted 1 hour after the test item instillation totally reversible on day 7.
- at the iris level: a congestion noted 1 hour after the test item instillation and totally reversible on day 3.
- at the corneal level: a moderate corneal opacity, noted 1 hour after the test item instillation and totally reversible on day 7.

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes)
Remarks:
Migrated information Criteria used for interpretation of results: other: CLASSIFICATION in accordance with the CLP regulation
Conclusions:
In conclusion, the results obtained, under these experimental conditions, enable to conclude that the test item UNDECANEDIOIC ACID must be classified R36 “irritating to eyes”, according to the criteria for the Directive 67/548 and category 2 “Irritating to eyes”, H319 in accordance with the Regulation (EC) No. 1272/2008.