Registration Dossier

Administrative data

Description of key information

Skin irritation / corrosion  (EU Method B.4): not irritating 
Eye irritation (EU Method B.5): not irritating
Respiratory irritation: no data available

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
01 - 04 Mar 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an established protocol and similar to an appropriate OECD guideline and in compliance with GLP.
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
(1984)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: young adults
- Housing: Animals were individually housed in plastic cages with a perforated floor
- Diet: 100 g per day (LK-01 and LK-04) standard laboratory animal diet (Hope Farms, Woerden, The Netherlands)
- Water: (tap/filtered) water, ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): 50 - 60
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
other: untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 50% (w/v)

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
3 days
Reading time points: 1, 24, 48 and 72 h
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: 6 cm² of the left flank of the animals
- Type of wrap if used: The test substance was spread on a patch of Metalline and mounted on permeable tape. This was applied to the left flank of each animal, the right flank being covered with the same dressing without test substance. Finally, the animals were wrapped in flexible bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The remaining test substance was removed using a dry tissue and subsequently a tissue moistened with tap water.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system
Irritation parameter:
erythema score
Basis:
other: mean of 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
edema score
Basis:
other: mean of 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
The test substance caused only very slight erythema in all three animals 1 h after removal of the test substance and were fully reversible within 24 hours post-application. Neither edema nor any signs of systemic toxicity were observed in any of the rabbits during the study period.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified
Executive summary:

A sample of Unislip 1753 was tested in the rabbit primary dermal irritation/corrosion test to determine its possible irritating or corrosive effects.

The flank skin of 3 albino rabbits was exposed to 0.5 gram of the test substance moistened with 0.5 ml Milli-RO water for 4 hours using semi-occlusive dressings. The test substance caused only very slight erythema in all three animlas, 60 minutes after removal of the dressings.

The primary skin irritaiton index amounted to 0. Based on these results, the test substance should be considered as minimally irritating to the skin.

According to the criteria laid own in Annex VI of the EEC Council Directive 76/548/EEC (amended by Directive 832/467/EEC), the test substance need not be labelled as a skin irritant.

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

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29 Feb - 07 Mar 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an established protocol and similar to an appropriate OECD guideline and in compliance with GLP.
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
(1984)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: 10 weeks
- Housing: Animals were individually housed in plastic cages with a perforated floor
- Diet: 100 g per day (LK-01 and LK-04) standard laboratory animal diet (Hope Farms, Woerden, The Netherlands)
- Water: (tap/filtered) water, ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 20
- Humidity (%): 50 - 65
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated contralateral eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:
single application without rinsing
Observation period (in vivo):
7 days
Reading time points: 1, 24, 48, 72 h and 7 days post-application
Number of animals or in vitro replicates:
3 females
Details on study design:
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: Pocket flash-light
Irritation parameter:
cornea opacity score
Basis:
other: mean of 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
other: mean of 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
chemosis score
Basis:
other: mean of 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
other: mean of 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0.89
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Approximately 1 h post-application two animals showed diffuse conjunctival redness and slight chemosis; the other animal showed slight conjunctival redness and slight chemosis. The conjuctival redness was fully reversible in one animal by day 3 and in the other two animals between days 3 and 7. The chemosis resolved within 24, 48 or 72 hours for each rabbit separately. Treatment of the eyes with fluorescein 24 hours after exposure revealed no epithelial damage in any of the animals.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified
Executive summary:

Instillation of approximately 60 mg of the test substance in one of the eyes of each of three albino rabbits resulted in slight to diffuse redness of the conjuctivae and slight chemosis. The conjuctival redness had resolved in one animal by day 3 and in the other two animals between days 3 and 7. The chemosis resolved within 24, 48 or 72 hours for each rabbit separately. Based on the estimated Draize score of 6 (60 minutes) the test substance should be classified as mildly irritating according to the scheme of Kay and Calandra. According to the criteria laid down in Annex VI of the EEC Council Directive 67/548/EC (amended by Directive 83/467/EEC), the test substance need not be labelled as an eye irritant.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation / corrosion

The skin irritating properties of CAS 112-84-5 were tested in a study according to EU Method B.4 under GLP conditions (Daamen, 1988). In the study, 0.5 g of the test substance moistened with 0.5 mL vehicle (water), was applied to the clipped skin of three female New Zealand White rabbits for 4 hours using a semi-occlusive dressing. The treated skin was observed and evaluated at 1, 24, 48 and 72 h post-application according to the Draize Scoring System. The test substance induced only very slight erythema (grade 1) in all animals one hour after the removal of the test substance. These effects were fully reversible within 24 hours post-application. Neither edema nor any signs of systemic toxicity were observed in any of the rabbits during the remaining study period.

Eye irritation

The eye irritating properties of CAS 112-84-5 were tested in a study according to EU Method B.5 under GLP conditions (Daamen, 1988). For the assessment of the eye irritation properties 0.1 mL of the undiluted test substance was instilled into the eyes of three female New Zealand White rabbits as a single treatment without rinsing of the eye. The eyes were examined and the changes were graded according to the Draize scoring system 1, 24, 48 and 72 hours as well as 7 days post-application. One hour post-application two animals showed diffuse conjunctival redness (grade 2) and slight chemosis (grade 1). The other animal showed slight conjunctival redness (grade 1) and slight chemosis (grade 1). The conjunctival redness was fully reversible in one animal by day 3 and in the other two animals between days 3 and 7. The chemosis resolved within 24, 48 or 72 hours for each rabbit separately. Mean values for chemosis and conjunctival redness were calculated to be 0.33 and 0.89, respectively No effects on cornea and iris were observed during the study period. 


Justification for selection of skin irritation / corrosion endpoint:
The study was carried out in accordance with an appropriate EU Method and in compliance with GLP.

Justification for selection of eye irritation endpoint:
The study was carried out in accordance with an appropriate EU Method and in compliance with GLP.

Justification for classification or non-classification

The available data on skin irritation of CAS 112-84-5 do not meet the criteria for classification according to Regulation (EC) No 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.

The available data on eye irritation of CAS 112-84-5 do not meet the criteria for classification according to Regulation (EC) No 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.