2,2'-[(1-methylethylidene)bis[(2,6-dibromo-4,1-phenylene)oxymethylene]]bisoxirane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Remarks:

In vivo skin irritatation study is available and therefore was used in the submission.

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29/06/1999-02/07/1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Brominated epoxy having epoxy equivalent of 400gr/eq
- Physical state:solid
- Lot/batch No.:B21E-86
- Expiration date of the lot/batch: 30/05/2014
- Storage condition of test material: under ambient conditions in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Nederland, The Netherlands
- Age at study initiation:at least 6 weeks
- Weight at study initiation:less than 3.5kg
- Housing:Individually housed in labelled cages with perforated floors (Scanbur Denmark) and equipped with an automatic drinking system.
- Diet (e.g. ad libitum): approx. 100g per day
- Water (e.g. ad libitum):ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C):21°C
- Humidity (%):50%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light):12 hours artificial fluorescent light, 12 hours dark

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: test substance was mistened with water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 of one sex

Details on study design:

TEST SITE
- Area of exposure:150cm²
- Type of wrap if used: a Metallin patch (2x3 cm) was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic badage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: four hours

SCORING SYSTEM:
EYRTHEMA AND ESCHAR FORMATION:
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness):4

OEDEMA FORMATION:
No oedema: 0
Very slight oedema (barely perceptible): 1
Slight oedema (edges of area well defined by definite raising): 2
Moderate oedema (raised approximately 1mm): 3
Severe oedema (raised more than 1mm and extending beyond area of exposure): 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 48 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24h

Score:

0

Max. score:

4

Results 7

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 48h

Score:

0

Max. score:

4

Results 8

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 72h

Score:

0

Max. score:

4

Irritant / corrosive response data:

no skin irritation was caused by 4 hours of exposure to F-2200HM

Other effects:

no other effects were reported

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commision Directive 93/21/EEC). F-2200HM does not have to be classified and has no obligatory labelling requirement for skin irritation.

Executive summary:

Primary skin irritation/corrosion study with F-2200HM in the rabbit (4 -hour semi-occlusive application).

The study was carried out based on the guidelines described in: EC Commission Directive 92/69/EEC, B.4: 'Acute Toxicity. Skin irritation' and OECD No. 404, 'Acute Dermal Irritation/Corrosion'.

Three rabbits were exposed to 0.5 gram of F-2200HM, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 hours after exposure.

No skin irriation was caused by 4 hours of exposure to F-2200HM.

Based on the results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC), F-2200HM does not have to be classified and has no obligatory labelling requirement for skin irritation.