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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1998
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Bromochloromethane
EC Number:
200-826-3
EC Name:
Bromochloromethane
Cas Number:
74-97-5
Molecular formula:
CH2BrCl
IUPAC Name:
bromo(chloro)methane
Constituent 2
Reference substance name:
2008263
IUPAC Name:
2008263

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: A local supplier to the testing laboratory
- Age at study initiation: at least 6 weeks old
- Weight at study initiation: less than 3.5 kg
- Housing: in labelled cages with perforated floors
- Diet :Standard laboratory diet
-Water: Free access to tap-water diluted with decalcified water.
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
Room temperature: 21oc
Relative humidity: 50%
air exchange rate: 15 changes per hour, 12 hr light and 12 hr darkness


IN-LIFE DATES: NDA

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Amount / concentration applied:
0.5 ml of BROMOCHLOROMETHANE
Duration of treatment / exposure:
Only 1 dose, the skin area was banded after application for 4 hours.
Observation period:
For Mortality- twice daily
For Toxicity- at least once daily
For Irritation- after removal of dressing-1, 24, 48, 72 hr. and 7, 14, 21 days.
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: afetr 1, 24, 72 h and 7 and 14 days
Score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: after 21 days
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: after 24, 48, 72h and 7 and 14 days
Score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: after 21 days
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: afetr 1, 24, 72 h and 7 and 14 days
Score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: after 1h
Score:
2
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: after 1 and 24 hr
Score:
2
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: after 48h
Score:
1
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: after 7 days
Remarks on result:
other: No scoring possible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: after 21 days
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: after 14 days
Score:
2
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: after 21 days
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: after 1 h
Score:
3
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: afetr 24, 48, 72 hr
Score:
2
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: after 7 and 14 days
Remarks on result:
other: No scoring possible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: after 21 days
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: after 1 and 24h
Score:
3
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: after 48 and 72 hr
Score:
2
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: after 7 and 14 days
Remarks on result:
other: No scoring possible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: after 21 days
Score:
0

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Necrosis signs appeared and formation of scar tissue.
Dermal application of CBM for 4 hr resulted in full thickness destruction of the skin.
Therefore CBM wasconsidered to be corrosive
Executive summary:

A primary skin irritation/corrosion study was performed on Bromochloromethane using 3 albino rabbits with weights less than 3.5 kg (4 hour exposure, tests sites intact) representing a worst case scenario for assessing irritation.

Erythema and edema were observed within 1 hour after exposure in one rabbit. Superficial grey/white discolouration of the skin (signs of superficial necrosis) and slight or moderate oedema were noted in the other 2 rabbits. Clear signs of necrosis had developed in all 3 rabbits within 24 hours after exposure. Based on the signs of necrosis and resulting formation of scar tissue, it was concluded that BROMOCHLOROMETHANE is considered to be corrosive.