Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
not specified
Adequacy of study:
supporting study
Study period:
Not specified
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
abstract
GLP compliance:
not specified
Specific details on test material used for the study:
Not specified
Remarks on result:
other: There is no evidence that a healthy individual will experience long-term health effects from open-air exposures to CS.
Irritant / corrosive response data:
There is no evidence that a healthy individual will experience long-term health effects from open-air exposures to CS.
Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
According to (Blain 2003) (abstract available only), substance CS is sometimes irritating to skin particularly in moist and warm areas
Executive summary:

According to (Blain 2003) (abstract available only), substance CS is sometimes irritating to skin particularly in moist and warm areas

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
abstract
GLP compliance:
not specified
Species:
rat
Amount / concentration applied:
10% W/V
Duration of treatment / exposure:
Not specified
Observation period:
Not specified
Number of animals:
Not specified
Details on study design:
Not specified
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
Preparation containing 10% W/V of CS occasionally produced eschar without purpura. Washing exposed skins with water or soap and water, at intervals up to 30 min after exposure, provided little benefit? Dermal recovery was substantially complete at 5 weeks.
Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
According to (Gaskins 1971) (abstract available only), substance CS applied to rabbit skin usually produced purpura and/or necrotic eschar, and dermal recovery was substantially complete after 5 weeks.
Executive summary:

According to (Gaskins 1971) (abstract available only), substance CS applied to rabbit skin usually produced purpura and/or necrotic eschar, and dermal recovery was substantially complete after 5 weeks.

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Version / remarks:
13 April 2004
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
substance CS at 5 % in MBIK and hexyl acetate solvents used (no dimetyl glutarate as mentioned in test material)
Test system:
human skin model
Source species:
human
Cell type:
other: epidermis cells
Cell source:
other: Not specified
Source strain:
other: human
Details on test system:
Episkin™ Reconstituted Human Epidermis Model
Amount/concentration applied:
5% in solvents MBIK or hexyl acetate
Duration of treatment / exposure:
3, 60, 240 minutes
Duration of post-treatment incubation (if applicable):
Not specified
Number of replicates:
Not specified
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
5% test material in hexyl acetate - exposure period 240 minutes
Value:
ca. 97.4
Vehicle controls validity:
not specified
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: non corrosive
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
5% test material in MBIK - exposure period 240 minutes
Value:
ca. 97.4
Vehicle controls validity:
not specified
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: non corrosive
Other effects / acceptance of results:
relative mean viability for positive control was 7.3% relative to the negative control treated tissues following 240 minutes exposure period: validity criterion satisfied
Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The results showed that the substance CS at 5% in either hexyl acetate or MIBK or dimethyl glutarate solutions is non-corrosive.
Executive summary:

According to study using Episkin Reconstituted Human Epidermis Model. which methodology follows OECD 431 standard, the results showed that the substance CS at 5% in either hexyl acetate or MIBK or dimethyl glutarate solutions is non-corrosive. The results were published by (Croft, 2003).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not specified
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
Not specified
Species:
cattle
Strain:
not specified
Vehicle:
other: Dimethyl glutarate, Hexyl acetate or MIBK
Controls:
yes, concurrent positive control
yes, concurrent negative control
Irritation parameter:
in vitro irritation score
Run / experiment:
5% in dimethyl glutarate
Value:
ca. 6.7
Vehicle controls validity:
not examined
Remarks:
"corrected values"
Negative controls validity:
valid
Remarks:
0,9% sodium chloride score 2.1 mild irritant
Positive controls validity:
valid
Remarks:
absolute ethanol score 53 moderate irritant
Remarks on result:
positive indication of irritation
Remarks:
mean score on 3 corneas per vehicule
Irritation parameter:
in vitro irritation score
Run / experiment:
5% in hexyl acetate
Value:
ca. 2.6
Vehicle controls validity:
not specified
Remarks:
idem
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of irritation
Remarks:
idem
Irritation parameter:
in vitro irritation score
Run / experiment:
5% in methyl isobutyl ketone
Value:
ca. 11.5
Vehicle controls validity:
not specified
Negative controls validity:
valid
Remarks:
idem
Positive controls validity:
valid
Remarks:
idem
Remarks on result:
positive indication of irritation
Other effects / acceptance of results:
Quality criteria required for acceptance of results in the test were satisfied
Interpretation of results:
Category 2B (mildly irritating to eyes) based on GHS criteria
Conclusions:
5% solutions of CS in dimethyl glutarate, hexyl acetate and MIBK were mild-irritants for the eyes (in vitro irritation score of 2.6 to 11.5, whereas positive control ethanol is 53).
Executive summary:

According to a BCOP assay following OECD 437 methodology, the results showed that 5% solutions of CS in dimethyl glutarate, hexyl acetate and MIBK were mild-irritants for the eyes (in vitro irritation score of 2.6 to 11.5, whereas positive control ethanol is 53). This result is published in (Croft, 2003).

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not specified
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
GLP compliance:
yes (incl. certificate)
Species:
other: human
Strain:
other: human corneal epithelium model
Vehicle:
other: Dimethyl glutarate, Hexyl acetate or MIBK
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
Not specified
Irritation parameter:
histopathological observations
Remarks:
% relative viability
Run / experiment:
5% in dimethyl glutarat
Value:
ca. 59.3
Vehicle controls validity:
not specified
Negative controls validity:
valid
Remarks:
100% viability in Solution A (composition described in study report)
Positive controls validity:
valid
Remarks:
50.8% viability in Sodium Dodecyl Sulphate
Remarks on result:
positive indication of irritation
Remarks:
triplicate SkinEthic tissues
Irritation parameter:
histopathological observations
Remarks:
% relative viability
Run / experiment:
5% in hexyl acetate
Value:
ca. 60.7
Vehicle controls validity:
not specified
Remarks:
idem
Negative controls validity:
valid
Remarks:
idem
Positive controls validity:
valid
Remarks:
idem
Remarks on result:
no indication of irritation
Remarks:
but not likely to be severe ocular irritant
Irritation parameter:
histopathological observations
Remarks:
% relative viability
Run / experiment:
5% in methyl isobutyl ketone
Value:
ca. 27.4
Vehicle controls validity:
not specified
Remarks:
idem
Negative controls validity:
valid
Remarks:
idem
Positive controls validity:
valid
Remarks:
idem
Remarks on result:
positive indication of irritation
Other effects / acceptance of results:
Quality criteria required for acceptance of results in the test were satisfied
Interpretation of results:
Category 2B (mildly irritating to eyes) based on GHS criteria
Conclusions:
5% solutions of CS in dimethyl glutarate and MIBK were irritant (% relative viability comparable to the positive control) whereas solution containing 5% CS in hexyl acetate was not likely to be a severe irritant.
Executive summary:

According to a study performed with SkinEthic Reconstituted Human Corneal Epithelium Model, following OECD 492 methodology, The results showed that 5% solutions of CS in dimethyl glutarate and MIBK were irritant (% relative viability comparable to the positive control) whereas solution containing 5% CS in hexyl acetate was not likely to be a severe irritant. This result is published in (Croft, 2003).

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
Not specified
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
abstract
Guideline:
other: Not specified
Principles of method if other than guideline:
Not specified
GLP compliance:
not specified
Specific details on test material used for the study:
Not specified
Species:
rat
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Not specified
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
Not specified
Duration of treatment / exposure:
Not specified
Observation period (in vivo):
Not specified
Duration of post- treatment incubation (in vitro):
Not specified
Number of animals or in vitro replicates:
Not specified
Details on study design:
Not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
CS produced no corneal injury
Other effects:
Not specified
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Executive summary:

CS produced no corneal injury

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Justification for classification or non-classification