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Diss Factsheets

Administrative data

Description of key information

Skin: Not irritating (OECD 404 / EU Annex V method B4)
Eye: Not irritating (OECD 405 / EU Annex V method B5)

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:
experimental study
Adequacy of study:
weight of evidence
Study period:
July 1990 - February 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 3.0 - 4.2 kg
- Housing: Metal cages
- Diet (e.g. ad libitum): Altromin 2123 rabbit diet, ad-libitum
- Water (e.g. ad libitum): Deionised water, ad-libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 deg C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

IN-LIFE DATES: From: 1990-07-24 To: 1990-07-27
Type of coverage:
semiocclusive
Preparation of test site:
clipped
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): 100% (undiluted)
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5x2.5 cm square
- % coverage: 100% over stated area
- Type of wrap if used: Fabric wound plaster held in place by semi-occlusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual material removed with lukewarm tap water
- Time after start of exposure: 4 hours

SCORING SYSTEM: According to Draize et.al as described in OECD test guideline
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Irritant / corrosive response data:
None observed
Other effects:
None observed
Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not irritating to the skin
Executive summary:

Potential irritation / corrosion following a single application to the intact skin of rabbits has been investigated. Methods followed those described by OECD Test Guideline No. 404 and EC Directive 84/449/EEC, B.4. A 0.5 mL aliquot of the substance was applied to a site of approximately 2.5 cm x 2.5 cm area of intact skin on each of 3 rabbits and covered by semi-occlusive dressing. The duration of the exposure was 4 hours. The treated skin was examined: 0.5-1, 24, 48 and 72 hours after exposure for evidence of reaction to treatment.

 

No effects of treatment were observed.

The substance is not irritating to the skin

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
February 1999 - July 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: J. Schitkovits, 2620 Natschbach, Austria
- Weight at study initiation: 2.6 - 2.7 kg
- Housing: Individual wire cages, 79x59x35 cm
- Diet (e.g. ad libitum): Altromin 2023 rabbit diet, ad-libitum
- Water (e.g. ad libitum): Tap water, ad-libitum
- Acclimation period: 11 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20deg C average
- Humidity (%): 54% average
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

IN-LIFE DATES: From: 1999-04-27 To: 1999-04-30
Type of coverage:
semiocclusive
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): 100% (undiluted)
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5x2.5 cm square
- % coverage: 100% over stated area
- Type of wrap if used: Cellulose patch held in place by "Blenderm" hypoallergenic surgical tape overlain by self adhesive non-woven fabric

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual material removed with wet Kleenex tissues
- Time after start of exposure: 4 hours

SCORING SYSTEM: According to Draize et.al as described in OECD test guideline
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Irritant / corrosive response data:
None observed
Other effects:
None observed
Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not irritating to the skin
Executive summary:

Potential irritation / corrosion following a single application to the intact skin of rabbits has been investigated. Methods followed those described by OECD Test Guideline No. 404 and EC Directive 92/69/EEC, B.4. A 0.5 mL aliquot of the substance was applied to a site of approximately 2.5 cm x 2.5 cm area of intact skin on each of 3 rabbits and covered by semi-occlusive dressing. The duration of the exposure was 4 hours. The treated skin was examined 1, 24, 48 and 72 hours after exposure for evidence of reaction to treatment.

 

No effects of treatment were observed.

The substance is not irritating to the skin

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
July 1990 - August 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 3.2 - 4.0 kg
- Housing: Metal cages
- Diet (e.g. ad libitum): Altromin 2123 rabbit diet, ad-libitum
- Water (e.g. ad libitum): Deionised water, ad-libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 deg C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

IN-LIFE DATES: From: 1990-07-31 To: 1990-08-07
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 100% (undiluted)
Duration of treatment / exposure:
Exposure at a single time point
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After 24 hours with physiological saline at 37 deg C

SCORING SYSTEM: Accoding to Draize et.al. as described by the OECD test method

TOOL USED TO ASSESS SCORE: fluorescein - slit lamp
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
Corneal opacity: In 2/3 animals corneal abnormalities were noted. Diffuse areas of opacity (score "1") were noted. In 1/3 animals easily discernible translucent areas (score of "2) with the whole cornea affected. The lesions were fully reversible after 7 days.
Iris inflammation: In 3/3 animals mild changes (score "1") were noted from 1 hour and remained for at least 72 hours.
Conjunctival redness: diffuse crimson colour to a diffuse beefy red (scores "2" and "3") were noted in all animals. The lesions were observed from 1 hour and remained for at least 72 hours. Recovery had occurred within 7 days.
Conjunctival chemosis: Significant swelling with a score of "3" was observed in 3/3 animals after 1 hour. In 2/3 animals swellings in different degrees of severity (scores "1" to "3") were noted from 24 - 72 hours. The lesions then gradually returned to normal and after 7 days no swelling was detectable.

Other effects:
None observed
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The substance is irritating to the eye
Executive summary:

The potential irritating / corrosive effects following a single administration into the eye of rabbits has been investigated. Methods followed those described in OECD Test Guideline No. 405 and EC Directive 92/69/EEC B.5. A 0.1 mL aliquot was instilled into the conjunctival sac of one eye of each of 3 rabbits. The treated eyes were examined 1, 24, 48 and 72 hours and 7 days following exposure.

 

In all 3 animals reversible corneal lesions (scattered areas of opacity) were observed, present for at least 72 hours in 2 of the 3 animals. In all animals the iris was mildly injected for up to 72 hours after exposure. Well defined to marked redness of the conjunctivae was observed in all 3 animals after 1 hour and remained for a maximum of 72 hours. Marked chemosis of the conjunctivae was seen in all animals for a maximum of 72 hours post exposure. Complete recovery had occurred within 7 days of exposure.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
February 1999 - July 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: J. Schitkovits, 2620 Natschbach, Austria
- Weight at study initiation: 2.6 - 3.4 kg
- Housing: Individual wire cages 79x59x35 cm
- Diet (e.g. ad libitum): Altromin 2023 rabbit diet, ad-libitum
- Water (e.g. ad libitum): Tap water, ad-libitum
- Acclimation period: At least 10 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 deg C average
- Humidity (%): 55% average
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

IN-LIFE DATES: From: 1999-04-27 To: 1999-05-07
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 100% (undiluted)
Duration of treatment / exposure:
Exposure at a single time point
Observation period (in vivo):
6 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not done

SCORING SYSTEM: Accoding to Draize et.al. as described by the OECD test method

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein - slit lamp
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 6 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: Not applicable
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: Not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 6 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
Corneal opacity: In 2/3 animals corneal abnormalities were noted. Diffuse areas of opacity (score "1") were noted in 2/3 animals with the whole cornea affected. The lesions were fully reversible after 24 or 72 hours. The cornea of the third animal was normal at all times.
Iris inflammation: In 2/3 animals mild changes (score "1") were noted from 1 hour and remained for a maximum of 72 hours.
Conjunctival redness: Injected blood vessels to a diffuse crimson colour (scores "1" and "2") were noted in all animals. The lesions were observed from 1 hour to a maximum of 72 hours.
Conjunctival chemosis: A slight swelling with a score of "1" was observed in 1/3 animals after 1 hour. In 2/3 animals swellings in different degrees of severity (scores "1" to "3") were noted from 1 hour onwards. The lesions then gradually returned to normal and after 72 hours no swelling was detectable.

Other effects:
None observed
Interpretation of results:
GHS criteria not met
Conclusions:
The substance is slightly irritating to the eye
Executive summary:

The potential irritating / corrosive effects following a single administration into the eye of rabbits has been investigated. Methods followed those described in OECD Test Guideline No. 405 and EC Directive 92/69/EEC B.5. A 0.1 mL aliquot was instilled into the conjunctival sac of one eye of each of 3 rabbits. The treated eyes were examined 1, 24, 48 and 72 hours and 6 days following exposure.

 

In 2 of the 3 animals reversible corneal lesions (scattered areas of opacity) were observed. In 1 of the 3 animals the iris was mildly injected 24 - 72 hours after exposure and in a second animal 1 hour after exposure. Very slight to pronounced redness of the conjunctivae was observed in all 3 animals after 1 hour and remained for a maximum of 72 hours. Slight to obvious chemosis of the conjunctivae was seen in all animals for a maximum of 48 hours post exposure.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Two tests for acute dermal irritation following 4 hours exposure to intact skin of the rabbit and two eye irritation tests in the rabbit have been undertaken.

Assessment has been based on these critical studies for the end-points.

The skin irritation studies show that the substance is not irritating to the skin. One eye irritation study indicates the substance, while exhibiting some irritation, should not be classified as irritant to the eye. The second study indicates the substance to be irritant. There is a variation in ocular response to the effects of the substance and there is justification for using all the available information, in a weight of evidence approach, by combining the 2 studies to account for the apparent variation. In both EU and GHS classification procedures there are difference in the manner in which the numerical scores asssigned to the severity of observed reaction is calculated, depending on the number of animals for which data are available. The weight of evidence from all the available information indicates that the degree of irritation observed is not of sufficient severity to require classification under either EU or GHS criteria.


Justification for classification or non-classification

Non classification is justified by the following:

In-vivo tests for skin irritation corrosion indicate that the substance is not irritant to the skin.

In-vivo tests for eye irritation indicate that the substance, while causing irritation to the eye, does not cause iritation at an incidence or sufficient severity / duration to require classification.