Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted prior to availability of the appropriate OECD and OPPTS testing guidelines. However, the study was well documented and is scientifically acceptable. Hence, it was identified as a key study and was graded klimisch 2.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Guideline is not known
Principles of method if other than guideline:
Dibromomethane was applied on surgical gauze and placed directly on the test site of rabbits back. After 24 hours the sheeting and gauze patches
were removed. Observation for signs of dermal irritation or other changes were recorded at 8, 24 and 48 hour intervals after application.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Dibromomethane
EC Number:
200-824-2
EC Name:
Dibromomethane
Cas Number:
74-95-3
Molecular formula:
CH2Br2
IUPAC Name:
dibromomethane
Details on test material:
unspecified purity, DBM. Clear, colourless liquid with a characteristic odour.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
No further information

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.5 ml of the test material
Duration of treatment / exposure:
24 hours
Observation period:
8, 24 and 48 hour intervals after application
Number of animals:
six
Details on study design:
Six New Zealand White (NZW) rabbits were closely clipped on the back and sides. The site to the left of the spinal column was abraded, while the site to the right of the spinal column was left intact. 0.5 ml of the test material (unspecified purity, Dibromomethane) was applied on surgical gauze squares 3 cm x and two
layers thick. The gauze was then placed directly on the test site. The animals were then wrapped with plastic sheeting which was secured with adhesive tape to keep the gauze in place. After 24 hours the sheeting and gauze patches were removed. Observation for signs of dermal irritation or other changes were
recorded at 8, 24 and 48 hour intervals after application utilizing the scoring system published in Federal Section 191.11 of the Federal Hazardous Substances Act of the United States. At each observation, all treated sites were scored for erythema (and eschar information), and edema formation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h
Score:
2.6
Max. score:
3
Remarks on result:
other: moderate to severe
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48h
Score:
1.33
Max. score:
2
Remarks on result:
other: slight, barely perceptible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h
Score:
2.1
Max. score:
3
Remarks on result:
other: slight, barely perceptible edema with raised edges
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48h
Score:
0.66
Max. score:
2
Remarks on result:
other: scored "none" oedema
Irritant / corrosive response data:
Dibromomethane caused moderate to severe skin irritation (erythema and oedema) to NZW rabbits.
Four out of the six rabbits demonstrated well defined to moderate-severe erythema.
None to slight-barely perceptible oedema with raised edges was observed in four out of the six rabbits.
Irritation lasted more than 48 hours following application. Scoring table is attached.
Other effects:
No further information

Applicant's summary and conclusion

Conclusions:
Dibromomethane caused moderate to severe skin irritation (erythema and oedema) to NZW rabbits.
None to slight-barely perceptible oedema with raised edges was observed.
Irritation lasted more than 48 hours following application.
Executive summary:

Dibromomethane caused moderate to severe skin irritation (erythema and oedema) to NZW rabbits. Four out of the six rabbits demonstrated moderate-severe erythema. Two out of the six rabbits demonstrated well defined erythrma. None to slight-barely perceptible edema with raised edges was observed in four out of the six rabbits. Irritation lasted more than 48 hours following application.