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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02/2008 to 05/2008

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 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

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

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage JANVIER (53940 Le Genest St Isle - France)
- Females (if applicable) nulliparous and non-pregnant: no
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 213 g to 238 g (males) and 203 g to 221 g (females)
- Housing: solid-bottomed clear polycarbonate cages with a stainless steel mesh lid; during the treatment, the animals were kept in an individual cage. At day 3, the animals were put into their cage by 2 or 3
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C to 22°C
- Humidity (%): 34 % to 52 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Duration of exposure:

24 hours

Doses:

2.000 mg/kg bw

No. of animals per sex per dose:

5 male
5 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing on day 2, 7 and 14.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

no indication of skin irritation up to the relevant limit dose level

Mortality:

not observed

Clinical signs:

none

Body weight:

normal weight evolution

Gross pathology:

no reveal treatment-related changes

Any other information on results incl. tables

Neither cutaneous reactions nor systemic clinical signs related to the administration of the test item were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No need for classificaton as "acute Tox." according to (EU) No. 1272/2008.

Executive summary:

The LD50 of the test item Bromo(hexahydro-2H-azepin-2-onato-N)magnesium is higher than 2,000 mg/kg body weight by dermal route in the rat.

No signs for skin corrosion or irritation.