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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
30.09.1996 to 15.10.1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Ministerium für Umwelt, Raumordnung und Landwirtschaft des Landes Nordrhein-Westfalen

Test material

Constituent 1
Chemical structure
Reference substance name:
(3-chloropropyl)diethoxymethylsilane
EC Number:
236-828-6
EC Name:
(3-chloropropyl)diethoxymethylsilane
Cas Number:
13501-76-3
Molecular formula:
C8H19ClO2Si
IUPAC Name:
(3-chloropropyl)(diethoxymethyl)silane; (3-chloropropyl)diethoxymethylsilane; (4-chloro-1,1-diethoxybutyl)silane

Test animals

Species:
rabbit
Strain:
other: small white Russian
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: MØllegaard Breeding/Research Centre Ltd
- Age at study initiation: 'adult'
- Weight at study initiation: 2.2-2.7 kg
- Housing: Individual in stainless steel cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 30.09.1996 To: 15.10. 1996

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL



Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: Dorsal trunk
- % coverage: No data
- Type of wrap if used: Semi-occlusive


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with warm water
- Time after start of exposure: four hours


SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
2.66
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritant / corrosive response data:
30-60 minutes after removal of the dressings two rabbits had grade 2 erythema and edema, and one had grade 1 erythema and edema. After 24 and 48 hours the irritation had worsened so that the erythma was grade 2 and 3 and the edema was grade 2 and 4. The irritation then gradually reversed until there were no signs of erythema and edema on Day 10.
Other effects:
Yellow skin discolouration in animal 1 after 24 and 48 hours was observed. Dry or flaky skin in all animals after about a week was also observed. There were signs of irritation beyond the exposure area in animal 1 at 24, 48 and 72 hours. There was no scarring in any of the animals. There were no signs of irritation by Day 14.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a skin irritation study conducted according to OECD 404 and to GLP, (3-chloropropyl)diethoxymethylsilane was irritating to the skin of small white Russian rabbits.