Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Based on the CLP application criteria guidance document the substance is not classified for Skin Irritation.

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:
key study
Study period:
30 January 1990 - 02 February 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: GLP, The United Kingdom Compliance Programme, Department of Health and Social Security 1986 and subsequent revision, Department of Health, 1989
Qualifier:
according to guideline
Guideline:
other: U.S. FDA, Title 21 Code of Federal Regulations Part 58, Federal Register, 22 December 1978 and subsequent Amendments
Qualifier:
according to guideline
Guideline:
other: United States Environmental Protection Agenct, (FIFRA) Title 40 Code of Federal Regulations Part 160, Federal Register, 29 November 1983 and subsequent amendment Federal Register 17 August 1989
Qualifier:
according to guideline
Guideline:
other: United States Environmental Protection Agency, (TSCA) Title 40 Code of Federal Regulations Part 792, Federal Register, 29 November 1983 and subsequent amendment Federal Register 17 August 1989
Qualifier:
according to guideline
Guideline:
other: Japan Ministry of Health and Welfare Notification No. Yakuhatsu 313 Pharmaceutical Affairs Bureau, 31 March 1982 and subsequent amendment Notification No. Yakuhatsu 870, Pharmaceutical Affairs Bureau, 5 October 1988
Qualifier:
according to guideline
Guideline:
other: Japan Ministry of Agriculture, Forestry and Fisheries, 59 NohSan, Notification No. 3850, Agricultural Production Bureau, 10 August 1984
Qualifier:
according to guideline
Guideline:
other: Japan Ministry of International Trade and Industry, Directive 31 March 1984
Qualifier:
according to guideline
Guideline:
other: OECD ISBN 92-64-12367-9, Paris 1982
GLP compliance:
yes
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 4 °C in the dark
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 11 to 14 weeks
- Weight at study initiation: 2.6 to 3.3 kg
- Housing: individually housed in metal cages with perforated floors
- Diet (e.g. ad libitum): free access to SDS Standard Rabbit Diet
- Water (e.g. ad libitum): free access to tap water
- Acclimation period: were acclimated (not specified how)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 19 °C
- Humidity (%): 30-70%
- Air changes (per hr): approximately 19 per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
yes, concurrent vehicle
Amount / concentration applied:
0.5g amount of isopropyl acrylamide moistured with 0.5 ml distilled water
Duration of treatment / exposure:
24 hours
Observation period:
72 hours after application
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm
- Type of wrap if used: ''Elastoplast'' elastic adhesive dressing backed with ''Sleek'' plaster

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped to remove any residual test substance
- Time after start of exposure: 24 hours

OBSERVATION TIME POINTS
24h and 72 h

SCORING SYSTEM:
Erythema and eschar formation:
- no erythema 0
- very slight erythema 1
- well-defined erythema 2
- moderate to severe erythema 3
- severe erythema to slight eschar formation 4

Oedema formation:
- no oedema 0
- very slight oedema 1
- slight oedema 2
- moderate oedema 3
- severe oedema 4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: No effect
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: No effect
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: No effect
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: No effect
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: No effect
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
72 h
Score:
0.7
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
edema score
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
edema score
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
edema score
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Interpretation of results:
GHS criteria not met
Conclusions:
Based on the CLP application criteria guidance document the substance is not classified for Skin Irritation.
Executive summary:

Based on the CLP application criteria guidance document the substance is not classified for Skin Irritation.

Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
other justification
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
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:
key study
Study period:
05 February 1990 - 09 February 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: GLP, The United Kingdom Compliance Programme, Department of Health and Social Security 1986 and subsequent revision, Department of Health, 1989
Qualifier:
according to guideline
Guideline:
other: U.S. FDA, Title 21 Code of Federal Regulations Part 58, Federal Register, 22 December 1978 and subsequent Amendments
Qualifier:
according to guideline
Guideline:
other: United States Environmental Protection Agenct, (FIFRA) Title 40 Code of Federal Regulations Part 160, Federal Register, 29 November 1983 and subsequent amendment Federal Register 17 August 1989
Qualifier:
according to guideline
Guideline:
other: United States Environmental Protection Agency, (TSCA) Title 40 Code of Federal Regulations Part 792, Federal Register, 29 November 1983 and subsequent amendment Federal Register 17 August 1989
Qualifier:
according to guideline
Guideline:
other: Japan Ministry of Health and Welfare Notification No. Yakuhatsu 313 Pharmaceutical Affairs Bureau, 31 March 1982 and subsequent amendment Notification No. Yakuhatsu 870, Pharmaceutical Affairs Bureau, 5 October 1988
Qualifier:
according to guideline
Guideline:
other: Japan Ministry of Agriculture, Forestry and Fisheries, 59 NohSan, Notification No. 3850, Agricultural Production Bureau, 10 August 1984
Qualifier:
according to guideline
Guideline:
other: Japan Ministry of International Trade and Industry, Directive 31 March 1984
Qualifier:
according to guideline
Guideline:
other: OECD ISBN 92-64-12367-9, Paris 1982
GLP compliance:
yes
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 4 °C in the dark
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: approximately 13 weeks
- Weight at study initiation: 2965 g
- Housing: individually housed in metal cage with a perforated floor
- Diet (e.g. ad libitum): free acess to SDS Standard Rabbit Diet
- Water (e.g. ad libitum): free access to tap water

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 19 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): approximately 19 per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light (07:00-19:00)
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
75 mg of isopropyl acrylamide
Observation period (in vivo):
Examination of eyes was made after 1 hour and 1, 2, 3 and 4 days after instalation
Number of animals or in vitro replicates:
1 rabbit
Details on study design:
SCORING SYSTEM:
Cornea
Opticity: degree of density
- no ulceration or opacity 0
- scattered or difuse areas of apacity 1
- easily discernible translucent areas, details of iris slightly obscured 2
- narcous areas, no details of iris visible, size of pupil barely discerrnible 3
- opaque cornea, iris not discernible through the opacity

Iris
- normal 0
- markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, any of these or combination of any thereof, iris still reacting light 1
- no reaction to light, haemorrhage, gross destruction 2

Conjunctivae
Redness
- blood vessels normal 0
- some blood vessels definitely hyperaemic 1
- diffuse, crimson colour, individual vessels not easely discernible 2
- diffuse, beefy red 3

Chemosis
- no swelling 0
- any swelling above normal 1
- obvious swelling with partial eversion of lids 2
- swelling with lids about half-closed 3
- swelling with lids more than half-closed 4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1 hour
Score:
0
Max. score:
4
Reversibility:
other: not reversible within 96 hours
Remarks on result:
other: A positive result in the one animal the study was terminated on humane grounds
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
other: not reversible within 96 hours
Remarks on result:
other: A positive result in the one animal the study was terminated on humane grounds
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
other: not reversible within 96 hours
Remarks on result:
other: A positive result in the one animal the study was terminated on humane grounds
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
other: not reversible within 96 hours
Remarks on result:
other: A positive result in the one animal the study was terminated on humane grounds
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 96 h
Score:
2
Max. score:
4
Reversibility:
other: not reversible within 96 hours
Remarks on result:
other: A positive result in the one animal the study was terminated on humane grounds
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
2
Reversibility:
other: not reversible within 96 hours
Remarks on result:
other: A positive result in the one animal the study was terminated on humane grounds
Irritation parameter:
iris score
Basis:
animal #1
Time point:
48 h
Score:
1
Max. score:
2
Reversibility:
other: not reversible within 96 hours
Remarks on result:
other: A positive result in the one animal the study was terminated on humane grounds
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
other: not reversible within 96 hours
Remarks on result:
other: A positive result in the one animal the study was terminated on humane grounds
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
other: not reversible within 96 hours
Remarks on result:
other: A positive result in the one animal the study was terminated on humane grounds
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
other: not reversible within 96 hours
Remarks on result:
other: A positive result in the one animal the study was terminated on humane grounds
Irritation parameter:
iris score
Basis:
animal #1
Time point:
72 h
Score:
1
Max. score:
2
Reversibility:
other: not reversible within 96 hours
Remarks on result:
other: A positive result in the one animal the study was terminated on humane grounds
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
other: not reversible within 96 hours
Remarks on result:
other: A positive result in the one animal the study was terminated on humane grounds
Irritant / corrosive response data:
There was no indication of reversibility of irritation up to 96 hours

The one treated animal gave a positive response.

A corneal opacity was observed 24 hours after instillation and persisted for the duration of the observation period.

Iridial inflammation was present two to four days following instillation.

A diffuse crimson-red colouration of the conjunctivae accompanied by obvious swelling with partial eversion of the eyelids and a copious discharge were observed.

Due to the severity of the ocular response only one animal was exposed to isopropyl acrylamide and the study was terminated on humane grounds four days after instillation.

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Instillation of Isopropyl acrylamide intothe rabbit eye elicited a posistive response in the one treated animal according to T.S.C.A test criteria.
There is no justiication for exposing further animals.
Executive summary:

·        Effects were irreversible after 4 days of observation.

·        Study was terminated on humane grounds four days after instillation

·        Based on the irreversible effects, the severity of the ocular response in one rabbit and that the study was terminated after testing in one rabbit on humane grounds it can be concluded that the substance is classified as “Causes serious Eye damage Category 1”.

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
other justification
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Justification for classification or non-classification

Skin irritation report classification

 

Based on the CLP application criteria guidance document the substance is not classified for Skin Irritation.

 

Wording from the guidance as follows:

 

Studies performed according to the USA Federal Hazardous Substances Act (US-FHSA), may be used for classification purposes although they deviate in their study protocol from the OECD TG 404. They do not include a 48-hour observation time and involve a 24-hour test material exposure followed by observations at 24 hour and 72 hours. Moreover, the test material is patched both on abraded and on intact skin of six rabbits. Studies usually are terminated after 72 hours. In case of no or minimal responses persisting until the 72 hours time points it is feasible to use such data for classification by calculating the mean values for erythema and oedema on the basis of only the 24 and 72 hours time points. Calculation of mean scores should normally be restricted to the results obtained from intact skin. In case of pronounced responses at the 72 hours time point an expert judgement is needed as to whether the data is appropriate for classification.

 

In case of 6 rabbits the following applies:

 

a.    Classification as skin corrosive – Category 1 if destruction of skin tissue (visible necrosis through the epidermis and into the dermis) occurs in at least one animal after exposure up to 4 hours.

 

b.    Classification as skin irritation – Category 2 if at least 4 out of 6 rabbits show a mean score per animal of ≥ 2.3 ≤ 4.0 for erythema/eschar or for oedema;

 

The study provided by KJ chemicals:

 

·        The study was conducted according USA regulations and does not include a 48 hour timepoint.

·        The study was only conducted with two timepoints 24 hours and 72hours.

·        No response at 72 hours therefore we can use this data for classification.

·        Study was conducted on 6 rabbits.

·        Mean values were calculated for Erythema and Oedema.

·        Mean Value for Erythema = 0.5

·        Mean Value for Oedema= 0.5 for 2 animals

·        Mean Value for Oedema= 0 for 4 animals

·        Based on the mean values the substance is not classified for Skin Irritation.

Eye irritation report classification

 

Based on the CLP application criteria guidance document the substance is classified for Eye Irritation.

 

Wording from the guidance as follows:

 

In vivo data

Tests in albino rabbits (OECD TG 405)

Evaluation criteria for local effects on the eye are severity of the damage and reversibility.

For the severity of damage the degree of inflammation is assessed. Responses are graded according to the grading of ocular lesions in OECD TG 405.

 

Evaluation takes place separately for cornea, iris and conjunctiva (erythema and swelling). If the scoring meets the criteria in CLP Annex I, Tables 3.3.1 and 3.3.2, the substances are classified as Category 1 for serious eye damage or Category 2 for eye irritation, respectively.

 

Reversibility of eye lesions is the other decisive factor in evaluating responses in the animal test. If the effects are not transient within the observation time of 21 days but cause persistent damage, they are considered irreversible and the test substance needs to be classified into Category 1. In the case of studies with a shorter observation period with irreversible effects, classification based on expert judgement should be considered.

 

With regard to reversibility the test report must prove that these effects are transient, i.e. the affected sites are repaired within the observation period of the test (see Example 1). Evaluation of reversibility or irreversibility of the observed effects does not need to exceed 21 days after instillation for the purpose of classification.

 

According to OECD TG 405, in cases of suspected serious eye damage, the test is started with one animal only. If effects in this animal are irreversible until the end of the observation period, sufficient information is available to classify the substance for serious eye damage. For a decision on no classification for serious eye damage and/or irritation or for a decision on classification as irritant, two additional animals have to be tested.

 

The study provided by KJ chemicals:

 

·        The study was conducted according USA regulations (EPA guidelines) however is similar to the OECD TG 405 Guidelines.

·        The study was only conducted on one rabbit due to the severity of the ocular response on only one animal tested.

·        Effects were irreversible after 4 days of observation.

·        Study was terminated on humane grounds four days after instillation

·        Based on the irreversible effects, the severity of the ocular response in one rabbit and that the study was terminated after testing in one rabbit on humane grounds it can be concluded that the substance is classified as “Causes serious Eye damage Category 1”.