Registration Dossier

Administrative data

Description of key information

The substance is irritating to the skin and corrosive to the eyes of rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study performed under GLP. Reliability reduced to take account of read across.
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: 16 CFR 1500.41
GLP compliance:
yes
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ace animals, Inc., Boyertown, PA, USA
- Age at study initiation: 'young adult'
- Weight at study initiation: 2.31-2.68 kg
- Housing: individually housed in wire mesh cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days minimum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Type of coverage:
occlusive
Preparation of test site:
other: clipped and then abraded on one side
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration (if solution): 31 %
Duration of treatment / exposure:
24 h
Observation period:
72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 1 inch square
- % coverage: no data
- Type of wrap if used: gauze patch and Blenderm tape then wrapped in occlusive binder.

REMOVAL OF TEST SUBSTANCE
- Washing : gently wiped with a clean gauze
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6 animals - intact skin
Time point:
other: 24.5 h post dose
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6 animals - intact skin
Time point:
other: 72 h post dose
Score:
3.3
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: slight eschar formation
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6 animals -abraded skin
Time point:
other: 24.5 h post dose
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6 animals - abraded skin
Time point:
other: 72 h post dose
Score:
3.3
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: slight eschar formation
Irritation parameter:
edema score
Basis:
mean
Remarks:
6 animals - intact skin
Time point:
other: 24.5 h post dose
Score:
0.83
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
mean
Remarks:
6 animals - intact skin
Time point:
other: 72 h post dose
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
6 animals - abraded skin
Time point:
other: 24.5 h post dose
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
mean
Remarks:
6 animals - abraded skin
Time point:
other: 72 h
Score:
0
Max. score:
4
Interpretation of results:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study performed under GLP. Reliability reduced for read across.
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: 16 CFR 1500.42
GLP compliance:
yes
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Ace Animals Inc., Boyertown, PA, USA
- Age at study initiation: 'young adults'
- Weight at study initiation: 2.27-2.48 kg
- Housing: Wire mesh bottom cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days minimum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 31%
Duration of treatment / exposure:
eyes not rinsed after instillation
Observation period (in vivo):
24, 48, 72 hours post instillation
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: not applicable

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: mean of 24, 48 & 72 h
Score:
0.67 - 1
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: not rinsed - 4 animals with score = 1; 2 animals score = 0 at 72h
Irritation parameter:
iris score
Basis:
mean
Time point:
other: mean of 24, 48 & 72 h
Score:
0.67 - 1
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: not rinsed - 5 animals with score =1; 1 animal with score = 0 at 72h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: mean of 24, 48 & 72 h
Score:
2 - 3
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: not rinsed
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: mean of 24, 48 & 72 h
Score:
2 - 3.7
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: not rinsed
Interpretation of results:
Category II
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A reliable skin irritation study performed using C8 alkane sulfonate and read across to the substance is available [FDRL (1985b)]. In this study, performed to 16 CFR 1500.41, 0.5 mL of a 31 % solution of the alkane sulfonate was applied under occlusive conditions to the skin (abraded and intact) of New Zealand White rabbits for 24 hours. The skin was observed for signs of irritation 24.5 and 72 hours after dosing. Mean erythema scores for intact skin of 2.0 and 3.3 were seen at 24.5 and 72 hours, respectively. Oedema scores of 0.83 and 0 were seen at these same time points. On the basis of these results, the substance is classified as a Category 2 skin irritant.

A reliable eye irritation study performed using C8 alkane sulfonate and read across to the substance is available [FDRL (1985c)]. In this study, performed to 16 CFR 1500.42, 0.1 mL of a 31% solution of the alkane sulfonate was instilled into the eyes of New Zealand White rabbits. Eyes were not rinsed and were examined at 24, 48 and 72 hours for signs of irritation. The mean scores for each animal for these time points ranged between 0.67-1 for cornea and iris, 2-3 for conjunctivae and 2-3.7 for chemosis. These effects were not fully reversible within 72 hours. On the basis of these results, the substance is classified as a Category 2 eye irritant.


Justification for selection of skin irritation / corrosion endpoint:
One study available

Justification for selection of eye irritation endpoint:
One study available

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: corrosive

Justification for classification or non-classification

The substance is classified as Skin Irritant Category 2 on the basis of the reactions seen in the in vivo skin irritation study.

The substance is classified as Eye Irritant Category 2 on the basis of the reactions seen in the in vivo skin irritation study.