Registration Dossier

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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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.