3,3'-methylenebis[5-methyloxazolidine]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Guideline study, well reported and documented according to good scientific standards

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,3'-methylenebis[5-methyloxazolidine]

EC Number:

266-235-8

EC Name:

3,3'-methylenebis[5-methyloxazolidine]

Cas Number:

66204-44-2

Molecular formula:

C9H18N2O2

IUPAC Name:

3,3'-methylenebis[5-methyloxazolidine]

Details on test material:

- Name of test material (as cited in study report): 3,3'-methylenebisoxazolidin/CAS-Nr. 66204-44-2
- Substance type: Reaction product from paraformaldehyde and 2 hydroxypropylamine (ratio of 3:2)
- Physical state: Clear colourless liquid
- Analytical purity: Activity > 99%
- Lot/batch No.: 24773
- Expiration date of the lot/batch: July 2002
- Storage condition of test material: At room temperature

Test animals

Species:

rabbit

Strain:

other: Little Russians, albino

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BI Pharma KG, D88397 Biberach
- Weight at study initiation: 2.5-2.8 kg
- Housing: Individually in PPO cages with perforated floor
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +-3
- Humidity (%): 55 +-15
- Air changes (per hr): 10 times
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From November 19, 2001 to December 18, 2001

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted

Duration of treatment / exposure:

Exposure period was 4 hours

Observation period:

Post-exposure period was 28 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: Dorsal area of the trunk
- % coverage: 10 cm x 10 cm
- Type of wrap if used: Gauze pads which were secured with adhesive Gothaplast® tape and further fixed with Gothaplast® tape wound around the trunk

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4hours

SCORING SYSTEM: Comparable to OECD 404 scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 to 72 hours

Score:

>= 3.2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: Day 28: scarring in two animals, one rabbit free of any signs of skin irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 to 72 hours

Score:

>= 2

Max. score:

2

Reversibility:

not reversible

Remarks on result:

other: Day 28: scarring in two animals, one rabbit free of any signs of skin irritation

Irritant / corrosive response data:

The mean scores for erythema and oedema are ≥ 2.0 at all reading times. Destruction of skin tissue was observed, the effects were not reversible: day 7 brown discolouration, necrotic tissue, demarcation in 2 rabbits; day 14 brown discolouration and demarcation or red coloured tissue with scales or red coloured tissue with scales plus necrotic tissue; day 21 2 animals with granulation tissue, one animal with intact skin; day 28 scarring in two animals, one rabbit free of any signs of skin irritation.

Any other information on results incl. tables

Table for skin irritation study

	time after start of exposure	Erythema	Edema
average Draize scores of 3 rabbits (0 to maximum 4)	1 h	2.8#	4.0
	24 h	2.5	2.0
	48 h	3.2##	2.0
	72 h	4.0##	2.0
reversibility:		No	No
#: brown discolouration in one animal (## in 2 animals)

Applicant's summary and conclusion

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Conclusions:

The test substance is corrosive. According to EEC directive 98/98/EC the test substance shall be classified as “causes burns”.

Executive summary:

Study according to OECD guideline 404. 3 rabbits exposed to 0.5 mL undiluted test substance for 4 hours. According to EEC Directive 98/98/EC the test substance shall be classified as “causes burns”. There was no complete reversibility after 28 days.