Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Crotyl chloride was tested for its skin irritant properties in rabbits. The study was performed according to OECD 404. With reference to the derived scores and the irreversibility during 21 days it is concluded that the substance is corrosive.


An in vivo eye irritation study in rabbits according to OECD 405 provided sligthly irritating effects to the eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
GLP compliance:
no
Remarks:
study prior to GLP requirements
Specific details on test material used for the study:
Purity: 99.9 %
Species:
rabbit
Strain:
other: White Russian
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source:Fa. Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: individually
- Diet: ad libitum, K12, Ssniff, Germany
- Water ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +- 1°C
- Humidity (%): 60 + 5%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted


Duration of treatment / exposure:
4 h exposure time, after 4h, dressing was removed and skin was washed with water
Observation period:
up to 21 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- % coverage:
- Type of wrap if used: gauze and polyethxlen foil, fixed with elastic bandage


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, water
- Time after start of exposure: 4h


SCORING SYSTEM: OECD Guideline
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
3.3 - 4
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: dark brown-reddish, hard scab or thinner eschar formation. From day one fur growth, from day 13. day detaching of the scab from outer side
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.33 - 2
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48, 72 h
Score:
5.21
Max. score:
8
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: single means: 1h: 4.67, 24h: 4.17; 48h: 6.0, 72h: 6.0
Irritant / corrosive response data:
after 48h to 72h post exposure, erythema score 4 were observed in all animals
dark brown-reddish, hard scab or thinner eschar formation. From day one fur growth, from day 13. day detaching of the scab from outer side
Other effects:
no systemic effects were reported
Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Conclusions:
Under conditions tested, the test substance showed severe effects on the skin after 4h exposure and is therefore considered to be corrosive.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
GLP compliance:
no
Remarks:
study was performed prior to GLP requirements
Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source:Fa. Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: individually
- Diet: ad libitum, K12, Ssniff, Germany
- Water ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +- 1°C
- Humidity (%): 60 + 5%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
not washed
Observation period (in vivo):
72h
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize (Appraisals of the safety of Chemicals in foods, drugs and Cosmetics, FDA, 1959)


TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1, 24, 48, 72h
Score:
23.33
Max. score:
110
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: max. observed score: 2 in one animal
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.52
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: max. observed score: 1 in one animal
Other effects:
no systemic effects were reported
Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under conditions tested, the test substance showed only slightly irritating effects to eyes
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Justification for classification or non-classification

With reference the reported scores and the irreversibility of skin corrosive effects it is concluded that the registration substance has to be classified  as corrosive according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).