Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23 October - 13 November 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non-GLP study conducted in compliance with OECD Guideline 405 with deviations: age at study initiation and individual animal weights not reported; environmental conditions not reported.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
age at study initiation and individual animal weights not reported; environmental conditions not reported
Principles of method if other than guideline:
Not applicable
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of sodium 3-{[3-(diethylamino)propyl]carbamoyl}-2-(dodecylamino)propanoate and sodium 3-{[3-(diethylamino)propyl]carbamoyl}-3-(dodecylamino)propanoate
EC Number:
939-579-8
Molecular formula:
Empirical Formula : C11H21N3O3Na C2nH4n+1 (n=4 – 9), C11H21N3O3NaC18H35, C11H21N3O3NaC18H33 Molecular formula of the two main constituents : C23H46N3O3Na
IUPAC Name:
Reaction mass of sodium 3-{[3-(diethylamino)propyl]carbamoyl}-2-(dodecylamino)propanoate and sodium 3-{[3-(diethylamino)propyl]carbamoyl}-3-(dodecylamino)propanoate
Details on test material:
- Name of test material (as cited in study report): Chimexane HB
- Physical state: Translucent pale yellow gel
- Lot/batch No.: M 405
- Date received: 09 October 1995
- Storage condition of test material: Room temperature, away from the light and heat

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: elevage BERTHO, Yffiniac, France
- Weight at study initiation: 2.4 kg (mean)
- Housing: Animals were housed individually on floor grid.
- Diet: Complete pelleted rabbit maintenance diet Energie H326 (COFNA, Tours, France), ad libitum
- Acclimation period: 5 days

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Undiluted test item
Duration of treatment / exposure:
No washing was done.
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: No

SCORING SYSTEM: According to OECD Guideline 405

TOOL USED TO ASSESS SCORE:
- Ocular reactions were performed with a U. V. and white magnification light. After recording the observations at 24 h, the eyes of all rabbits were examined with the aid of fluorescein.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
3.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
- One hour after instillation of the substance, important irritation reactions were noticed in all animals, at the level of the conjunctivae (diffuse beefy red enanthemae, abundant discharge, chemosis with lids about half closed). Iris congestion was also observed.
- 24 h later, chemosis increased in two rabbits and a distinct corneal opacity was visible in three rabbits. All irritation phenomena regressed very slowly. Within about a week they disappeared in two animals.
- Irritation signs persisted in one animal at the end of the observation period (21 days)
Other effects:
No data

Any other information on results incl. tables

Table 7.3.2/1: Results of eye irritation

Animal no.

4615

4640

4641

 

Conjunctiva

Iris

Cornea

Conjunctiva

Iris

Cornea

Conjunctiva

Iris

Cornea

 

A

B

C

D

E

F

A

B

C

D

E

F

A

B

C

D

E

F

D1 (1 h)

3

3

3

1

0

0

3

3

3

1

0

0

3

3

3

1

0

0

24 h

4

3

3

1

2

4

4

3

3

1

2

3

3

2

3

1

2

2

48 h

4

3

3

1

2

2

3

2

3

1

2

2

2

1

3

1

2

1

72 h

4

2

3

1

2

2

3

2

3

1

1

1

1

1

3

1

2

1

M

4.0

2.7

3.0

1.0

2.0

2.7

3.3

2.3

3.0

1.0

1.7

2.0

2.0

1.3

3.0

1.0

2.0

1.3

D5

3

1

3

1

4

2

1

1

2

1

1

1

1

1

2

1

2

1

D6

2

1

2

1

3

2

1

1

1

1

1

1

1

1

1

1

1

1

D7

2

1

2

1

2

2

0

0

0

0

0

0

0

0

0

0

0

0

D8

1

1

2

1

2

1

-

-

-

-

-

-

-

-

-

-

-

-

D9

1

1

2

1

2

1

-

-

-

-

-

-

-

-

-

-

-

-

D10

1

1

2

1

2

1

-

-

-

-

-

-

-

-

-

-

-

-

D11

1

1

3

1

2

1

-

-

-

-

-

-

-

-

-

-

-

-

D12

3

1

3

1

2

1

-

-

-

-

-

-

-

-

-

-

-

-

D13

3

1

3

1

2

1

-

-

-

-

-

-

-

-

-

-

-

-

D14

3

1

3

1

2

1

-

-

-

-

-

-

-

-

-

-

-

-

D15

3

1

3

1

2

1

-

-

-

-

-

-

-

-

-

-

-

-

D16

3

1

3

1

2

1

-

-

-

-

-

-

-

-

-

-

-

-

D17

3

1

3

1

2

1

-

-

-

-

-

-

-

-

-

-

-

-

D18

3

1

3

1

2

1

-

-

-

-

-

-

-

-

-

-

-

-

D19

3

2

3

1

2

1

-

-

-

-

-

-

-

-

-

-

-

-

D20

3

1

3

1

2

1

-

-

-

-

-

-

-

-

-

-

-

-

D21

1

1

2

0

1

1

-

-

-

-

-

-

-

-

-

-

-

-

D22

1

1

2

0

1

1

-

-

-

-

-

-

-

-

-

-

-

-

 

A: Chemosis; B: Discharge; C: Redness; D: Iris lesion; E: Opacity; F: Opacity area; M: Mean

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, Chimexane HB is classified as “R36 irritating to eyes”, according to the Annex VI of the Directive 67/548/EEC and ‘Category 1’ according to the Regulation (EC) N° 1272-2008 (CLP).
Executive summary:

In a non-GLP eye irritation study conducted according to the OECD Guideline 405, 3 healthy male rabbits of the New Zealand White strain were exposed to 0.1 mL of undiluted test item Chimexane HB in their right eye while the left eye remained untreated and served as control. The eyelids were then gently held together for about one second to avoid any loss of test item. At 24 h after treatment, fluorescein solution was instilled into the eyes and they were examined under UV-lamp to detect possible corneal damage. The eyes were examined and the changes were observed at 1, 24, 48 and 72 h and up to Day 22 after treatment and graded according to the method of OECD Guideline 405.

One hour after tiest item instillation, irritations of the palpebral and bulbar conjunctivae (enanthemae, discharge and chemosis) and iris congestion were noticed. 24 h later, chemosis increased in two rabbits and a distinct corneal opacity was visible in three rabbits. All irritation phenomena regressed very slowly. Within about a week they disappeared in 2 animals. Irritation signs persisted in one animal at the end of the observation period (21 days). Mean individual scores for the three animals at 24, 48 and 72 h post instillation were 2.0, 1.7, 2.0 for cornea score; 1.0, 1.0, 1.0 for iris score; 3.0, 3.0, 3.0 for conjunctivae score and 4.0, 3.3, 2.0 for chemosis score. In this study, Chimexane HB is an eye irritant on male rabbits.

Under the test conditions, Chimexane HB is classified as “R36 irritating to eyes”, according to the Annex VI of the Directive 67/548/EEC and ‘Category 1’ according to the Regulation (EC) N° 1272-2008 (CLP).