Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: DOT Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: DOT
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Dichloro(chloromethyl)methylsilane
EC Number:
216-319-5
EC Name:
Dichloro(chloromethyl)methylsilane
Cas Number:
1558-33-4
IUPAC Name:
dichloro(chloromethyl)methylsilane
Constituent 2
Reference substance name:
Silane, dichloro(chloromethyl)methyl-
IUPAC Name:
Silane, dichloro(chloromethyl)methyl-
Details on test material:
Purity 98 %

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
The rabbits were assigned animal numbers using a computerized randomization process. This proc-ess involved generating random numbers, assigning the random numbers to the animals, and rank-ing the random numbers. Using this randomly ranked list, six male rabbits were assigned to this study. The rabbits were identified uniquely by individual ear tags and housed individually in elevated metal cages. Commercial rabbit ration (Purfna Lab Rabbit Chow ,5321) and tap water were available at libitum except where noted otherwise. The rabbits were acclimated to laboratory conditions for a minimum of one week prior to initiation of treatment. Rabbits were used in this study because they have historically been used in safety evaluation studies and are required by appropriate regulatory agencies.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
not specified
Controls:
no
Amount / concentration applied:
0,5 ml
Duration of treatment / exposure:
4 hr
Observation period:
none
Number of animals:
6 males
Details on study design:
Prior to treatment, the dorsal area of each rabbit was clipped free of hair. and one site was chosen for application. A 0.5 ml aliquot of the test material was introduced onto each intact site under a one by one inch square gauze patch (two layers thick) which was secured in place with transparent tape. The trunk of each rabbit was wrapped with impervious rubber damming. The rabbits were then im-mobilized in stocks for four hours without food and water. Four hours following application, the bind-ers and patches were removed, and the exposure sites were washed with water to preclude further exposure of the animal to the test material. The test material was administered dermally because potential human exposure is by the dermal route.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 4 h
Reversibility:
not reversible
Remarks on result:
other: substance was corrosive to the skin

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
The substance is corrosive to the skin
Executive summary:

The test material chloromethyl-methyl-dichlorosilane. was evaluated for skin corrosivity potential in rabbits following a single dermal application. Extreme blanching and blackened tissue was observed in all rabbits at four hours post application. No edema or other dermal effects were noted. Due to the skin destruction,. the animals were sacrificed four hours after application of test material.