[(2-chlorophenyl)methylene]malononitrile

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

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

Reference 2

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.

Reference 3

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

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)

Version / remarks:

13 April 2004

GLP compliance:

yes (incl. QA statement)

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

Reference

Reference 1

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

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. QA statement)

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).

Reference 2

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

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. QA statement)

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).

Reference 3

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)