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

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin corrosion: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because an acute toxicity study by the dermal route does not indicate skin irritation up to the relevant limit dose level (2 000 mg/kg body weight)

Reference 2

Endpoint:

skin irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because an acute toxicity study by the dermal route does not indicate skin irritation up to the relevant limit dose level (2 000 mg/kg body weight)

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (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:

01/2008 to 03/2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

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

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

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

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24 h

Score:

2

Max. score:

2

Irritation parameter:

chemosis score

Basis:

mean

Time point:

48 h

Score:

2

Max. score:

2

Irritation parameter:

chemosis score

Basis:

mean

Time point:

72 h

Score:

2

Max. score:

2

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

24 h

Score:

2

Max. score:

2

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

48 h

Score:

2

Max. score:

2

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

72 h

Score:

2

Max. score:

2

Irritation parameter:

iris score

Remarks:

lesion

Basis:

mean

Time point:

24 h

Score:

1

Max. score:

1

Irritation parameter:

iris score

Remarks:

lesion

Basis:

mean

Time point:

48 h

Score:

0.7

Max. score:

1

Irritation parameter:

iris score

Remarks:

lesion

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

0

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24 h

Score:

2

Max. score:

2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

48 h

Score:

1.4

Max. score:

2

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.

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Justification for classification or non-classification

Skin corrosion / skin irritation:

Classification according to the CLP-regulation as "Skin Irrit. 2":

Bromo(hexahydro-2H-azepin-2 -onato-N)magnesium hydrolyses under physiological conditions with the formation of epsilon-Caprolactam and basic magnesium bromide. Additionally, epsilon-caprolactame is contained up to 80% in the substance as a stabiliser. Therefore also the effects of epsilon-caprolactame have to be taken into consideration. Epsilon-caprolactame is harmonised classified into "Skin Irrit.", category 2, H315. Thus, Bromo(hexahydro-2H-azepin-2 -onato-N)magnesium is classified into the hazard category "Skin Irrit.", category 2, H315, too.

Eye irritation:

Classified according to the CLP-regulation as "Eye Irrit. 2" on the basis of in-vivo test data.

Inhalative irritation:

A test on the inhalative toxicity / inhalative irritation of Bromo(hexahydro-2H-azepin-2 -onato-N)magnesium is not available. However, the substance hydrolyses under physiological conditions with the formation of epsilon-Caprolactam and basic magnesium bromide. Since epsilon-Caprolactam is classifed as "STOT SE 3", H335, Bromo(hexahydro-2H-azepin-2-onato-N)magnesium will be classified correspondingly.