1-bromo-3-chloro-2-methylpropane

Endpoint summary

Description of key information

Acute dermal irritation test for 1 -bromo-3 -chloro-2 -methylpropane was conducted. Under this test conditions this product is classified as not irritating based on GHS criteria.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994-11-22 to 1995-3-21

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1992

Qualifier:

according to guideline

Guideline:

other: EPA (TSCA) Pesticide Assessment Guidelines

Version / remarks:

1985

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Batch NO. 48241

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Limited.
- Housing: Stainless steel cages mounted in mobile batteries. The cages were fitted with perforated counter-sink floor pannels. A tray beneath the floor was line with absorbent paper which was chnaged regularly.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not kbown

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18C (15 - 23C)
- Humidity (%): 55 %R.H. (40 - 70% R.H.)
- Air changes (per hr): at least 10 times per hours
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light

IN-LIFE DATES: From: To: Day 14 after treatment

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

amount applied : 0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours after removal of badages.
Additional observations of persistent effects of treatment were made on Days 7, 10 and 13.
The reaction of the test sites were assessed according to the criteria of Draize.

Number of animals:

6 male rabbits

Details on study design:

Each rabbit was securely restrained by a technician. Two test sites (6 x 6 cm) were marked on either side of the clipped area of dorsum. A single dose was applied directly to the skin and covered by an unmedicated gauze patch (3 x 2 cm) which was held in place on the left test site by strips of Blenderm (Community Care products, 3M Health Care, Loughborough, England). The right test site, acting as a control, was covered by a similar semi-occlusive dressing but otherwise remained untreated. Pads of cotton wool and elasticated bandage were used to protect the patches and ensure good contact between the skin and test material during the four-hour exposure period.
The dressings were removed after four hours exposure; the treatment sites were gently washed with warm water and dried with paper tissues to remove excess test material adheringto the skin.

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1 h after removal of dressing

Score:

1.8

Max. score:

2

Reversibility:

fully reversible within: 10 dats

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 10 days

Irritation parameter:

erythema score

Basis:

mean

Time point:

48 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 10 days

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 10 days

Irritation parameter:

erythema score

Basis:

mean

Time point:

7 d

Score:

0.2

Max. score:

1

Reversibility:

fully reversible within: 10 days

Irritation parameter:

erythema score

Basis:

mean

Time point:

10 d

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 13 days

Score:

0

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1 hour after removal

Score:

1.5

Max. score:

2

Reversibility:

fully reversible within: 13 days

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 13 days

Irritation parameter:

edema score

Basis:

mean

Time point:

48 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 13 days

Irritation parameter:

edema score

Basis:

mean

Time point:

72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 13 days

Irritation parameter:

edema score

Basis:

mean

Time point:

7 d

Score:

0.8

Max. score:

1

Reversibility:

fully reversible within: 13 days

Irritation parameter:

edema score

Basis:

mean

Time point:

10 d

Score:

0.7

Max. score:

1

Reversibility:

fully reversible within: 13 days

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 13 days

Score:

0

Irritant / corrosive response data:

During the first hour following bandage removal, well-defined erythema was observed in five rabbits and very slight erythema in one. Slight edima was observed was observed in three rabbits and very slight edema in three rabbits at this time. At the 24, 48, and 72 hour examinations, very slight erythema and very slight edema were observed in all rabbits.
On Day 7, one rabbit showed very slight erythema and edema and four rabbits showed very slight edema. On Day 10, very slight edema persisted in four of these rabbits.
The test site of one rabbit was overtly normal on Day 7, another Day 10 and the remaining four animals on Day 13.
The control sites did not show any response to the control procedure.

Scoring of irritance responses

  Test site: 0.5 ml 2-MBCP  Control site: No treatment

  Semi-occluded for four hours

Animal No. and sex	Type of Response	Score after removal of dressing
		1 hour		24 hours		48 hours		72 hours
		Test site	Control site	Test site	Control site	Test site	Control site	Test site	Control site
32TD 602M	Erythema	2	0	1	0	1	0	1	0
	Edema	1	0	1	0	1	0	1	0
32TD 605M	Erythema	1	0	1	0	1	0	1	0
	Edema	1	0	1	0	1	0	1	0
32TD 612M	Erythema	2	0	1	0	1	0	1	0
	Edema	1	0	1	0	1	0	1	0
32TD 617M	Erythema	2	0	1	0	1	0	1	0
	Edema	2	0	1	0	1	0	1	0
32TD 619M	Erythema	2	0	1	0	1	0	1	0
	Edema	2	0	1	0	1	0	1	0
32TD 620M	Erythema	2	0	1	0	1	0	1	0
	Edema	2	0	1	0	1	0	1	0

 

 

 

Animal No. and sex	Type of Response	Score after removal of dressing
		Day 7		Day 10		Day 13
		Test site	Control site	Test site	Control site	Test site	Control site
32TD 602M	Erythema	0	0	0	0	0	0
	Edema	1	0	1	0	0	0
32TD 605M	Erythema	0	0	0	0	0	0
	Edema	0	0	0	0	0	0
32TD 612M	Erythema	0	0	0	0	0	0
	Edema	1	0	1	0	0	0
32TD 617M	Erythema	1	0	0	0	0	0
	Edema	1	0	1	0	0	0
32TD 619M	Erythema	0	0	0	0	0	0
	Edema	1	0	1	0	0	0
32TD 620M	Erythema	0	0	0	0	0	0
	Edema	1	0	0	0	0	0

 

 

Interpretation of results:

GHS criteria not met

Conclusions:

Under test conditions of this test, 1-bromo-3-chloro-2-methylpropane was considered to be "slightly irritant" to skin.
This result does not met GHS criteria for skin irritation.

Executive summary:

Under test conditions of this test, 1-bromo-3-chloro-2-methylpropane was considered to be "slightly irritant" to skin.

This result does not met GHS criteria for skin irritation. This substance is not irritate to skin.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)