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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline and GLP compliant study with good documentation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-chloroethyldiethylammonium chloride
EC Number:
212-786-4
EC Name:
2-chloroethyldiethylammonium chloride
Cas Number:
869-24-9
Molecular formula:
C6H14ClN.ClH
IUPAC Name:
2-chloroethyldiethylammonium chloride
Details on test material:
- Name of test material (as cited in study report): P5524
- Substance type: Powder
- Physical state: white powder
- Analytical purity: 102%
- Purity test date: 4. 1. 1990
- Lot/batch No.: 861201
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Maston, Sandbach, Cheshire, U.K.
- Weight at study initiation: 2.19 - 2.26 kg/animal
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 22°C
- Humidity (%): 49 - 67%
- Air changes (per hr): 15 cycles/hour
- Photoperiod (hrs dark / hrs light): 12/12 hours

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg of the test substance were placed on a moistered gauze pad which was then applied to the right flank (application for 4 hours) or the left flank (application for 3 minutes)
Duration of treatment / exposure:
4 hours
Observation period:
approximately 1 hours, 24, 48, and 72 hours after removal of dressing
Number of animals:
three animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Four hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.

SCORING SYSTEM:
Draize J.H. (1959) Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics"

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: haemorrhage of the dermal capilaries
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Remarks on result:
other: haemorrhage of the dermal capilaries
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 48 and 72 h
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: evaluation of erythema not possible due to other adverse reactions, hardened dark brown/black-coloured scab, blanching, moderate erythema surrounding scab
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 7 days
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: evaluation of erythema not possible due to other adverse reactions, hardened dark brown/black-coloured scab
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 14 days
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: evaluation of erythema not possible due to other adverse reactions, scab lifting at edges to reveal dried blood
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 1 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: haemorrhage of the dermal capilaries
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: haemorrhage of the dermal capillaries, reaction extends beyond treatment site, blanching
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 48 and 72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: blanching
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 7 days
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: evaluation of erythema not possible due to other adverse reactions, hardened dark brown/black-coloured scab, dried blood
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 14 days
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: evaluation of erythema not possible due to other adverse reactions, sunken hardened dark brown/black-coloured scab resembling a crater
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 1 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: haemorrhage of the dermal capillaries
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: haemorrhage of the dermal capillaries, blanching
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 7 days
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: evaluation of erythema not possible due to other adverse reactions, hardened dark brown/black-coloured scab, blanching
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 14 days
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: evaluation of erythema not possible due to other adverse reactions, scab lifting at edges to reveal dried blood
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1, 24, and 48 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 72 hours, 7 and 14 days
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: evaluation of oedema not possible due to the degree of thickening/ scabbing
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 1, 24, 48, and 72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 7 and 14 days
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: evaluation of oedema not possible due to the degree of thickening/ scabbing
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 1, 24, and 48 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: At 7 and 14 days: evaluation of oedema not possible due to the degree of thickening/ scabbing
Irritant / corrosive response data:
Well-defined or moderate erythema with moderate to severe oedema was noted during the study. Other adverse reactions noted were haemorrhage of the dermal capillaries, hardened dark brown/black-coloured scab, moderate erythema surrounding scab, blanching, dried blood, scab lifting at edges to reveal further dried blood and sunken hardened dark brown/black-coloured scab resembling a crater. At some treated skin sites the reaction extended beyond the treatment site. Reactions were indicative of corrosion.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

The acute dermal irritation of P5524- which contains 102% DEC - to rabbit (New Zealand White) was determined in a GLP compliant test according to OECD 404 and EU Method B.4 (Coles 1990). Since the study was performed under GLP and according the guideline and based on the good documentation the study was awarded with Klimisch 1. For the acute dermal irritation testing in 3 rabbits (2 males and one female, approx. weight of 2.19 - 2.26 g on day of application) 500 mg test item moistened with water was administered to the clipped skin. Application was performed for 4 hours.

 

The skin were examined according Draize J.H. (1959). Well-defined or moderate erythema with moderate to severe oedema was noted during the study. Other adverse reactions noted were haemorrhage of the dermal capillaries, hardened dark brown/black-coloured scab, moderate erythema surrounding scab, blanching, dried blood, scab lifting at edges to reveal further dried blood and sunken hardened dark brown/black-coloured scab resembling a crater. At some treated skin sites the reaction extended beyond the treatment site. Reactions were indicative of corrosion.

 

It can be concluded that under the experimental conditions the test substance is corrosive when administered by dermal route to rabbits.

 

According to the classification criteria laid down in the Commission Directive 93/21/EEC the test item required to be classified as corrosive to the skin.