Bromo(hexahydro-2H-azepin-2-onato-N)magnesium

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01/2008 to 03/2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Bromo(hexahydro-2H-azepin-2-onato-N)magnesium

EC Number:

241-158-2

EC Name:

Bromo(hexahydro-2H-azepin-2-onato-N)magnesium

Cas Number:

17091-31-5

Molecular formula:

C6H10BrMgNO

IUPAC Name:

magnesium(2+) ion 2-oxoazepan-1-ide bromide

additive 1

Reference substance name:

ε-caprolactam

EC Number:

203-313-2

EC Name:

ε-caprolactam

Cas Number:

105-60-2

Molecular formula:

C6H11NO

IUPAC Name:

azepan-2-one

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 07072601
- Expiration date of the lot/batch: 26.07.2008

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: no

FORM AS APPLIED IN THE TEST (if different from that of starting material): powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Elevage de Gerome (Quartier Labaste F40260 Linxe)
- Age at study initiation: 11 weeks
- Weight at study initiation: 2.24 to 2.99 kg
- Housing: individual boxes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 22
- Humidity (%): 39 to 57
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

72 h

Observation period (in vivo):

9 days

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM:
Chemosis (A): 0 to 4 credits
Discharge (B): 0 to 3 creditis
Redness (C): 0 to 3 creditis
Iris (D): 0 to 2 creditis
Cornea; degree of opacity: 0 to 4 creditis
Cornea: extent of opacity: 1 to 4 creditis

TOOL USED TO ASSESS SCORE: visual

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24 h

Score:

2

Max. score:

2

Results 2

Irritation parameter:

chemosis score

Basis:

mean

Time point:

48 h

Score:

2

Max. score:

2

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

72 h

Score:

2

Max. score:

2

Results 4

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

24 h

Score:

2

Max. score:

2

Results 5

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

48 h

Score:

2

Max. score:

2

Results 6

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

72 h

Score:

2

Max. score:

2

Results 7

Irritation parameter:

iris score

Remarks:

lesion

Basis:

mean

Time point:

24 h

Score:

1

Max. score:

1

Results 8

Irritation parameter:

iris score

Remarks:

lesion

Basis:

mean

Time point:

48 h

Score:

0.7

Max. score:

1

Results 9

Irritation parameter:

iris score

Remarks:

lesion

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

0

Results 10

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24 h

Score:

2

Max. score:

2

Results 11

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

48 h

Score:

1.4

Max. score:

2

Results 12

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

72 h

Score:

0.7

Max. score:

2

Irritant / corrosive response data:

The ocular reactions observed during the study have been slight to moderate, and totally reversible in the three animals:
- at the conjunctivae level: a moderate redness, noted 1 hour after the test item instillation and totally reversible between D8 and D9, associated with a moderate chemosis, noted 1 hour after the test item instillation and totally reversible between D7 and D9,
- at the corneal level: a slight to moderate opacity, registered 1 hour after the test item instillation and totally reversible between D3 and D4,
- at the iris level: a congestion registered 24 hours after the test item instillation in one animal and between D 1 and D2 in two other animals.
Moreover, it was noted a corneal neo-vascularisation at D2, in one animal.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

In accordance with regulation (EC) No. 1272/2008, the test item needs to be classified into the hazard class "serious eye damage / eye irritation", category 2, H319.