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Diss Factsheets

Administrative data

Description of key information

The substance is irritating to the skin and 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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Common functional groups

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to attached justification

3. ANALOGUE APPROACH JUSTIFICATION
Please refer to attached justification

4. DATA MATRIX
Please refer to attached justification
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: 16 CFR 1500.41
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
intact skin
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: 1st reading 0.5h after 24h dosing. no reading at 48 h. Slight eschar formation at 72h
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
intact skin
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: 1st reading 0.5h after 24h dosing. no reading at 48 h. Slight eschar formation at 72h
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
intact skin
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: 1st reading 0.5h after 24h dosing. no reading at 48 h. Slight eschar formation at 72h
Irritation parameter:
erythema score
Basis:
animal #4
Remarks:
intact skin
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: 1st reading 0.5h after 24h dosing. no reading at 48 h
Irritation parameter:
erythema score
Basis:
animal #5
Remarks:
intact skin
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: 1st reading 0.5h after 24h dosing. no reading at 48 h
Irritation parameter:
erythema score
Basis:
animal #6
Remarks:
intact skin
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: 1st reading 0.5h after 24h dosing. no reading at 48 h. Slight eschar formation at 72h
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
intact skin
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: 1st reading 0.5h after 24h dosing. no reading at 48 h.
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
intact skin
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: 1st reading 0.5h after 24h dosing. no reading at 48 h.
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
intact skin
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: 1st reading 0.5h after 24h dosing. no reading at 48 h.
Irritation parameter:
edema score
Basis:
animal #4
Remarks:
intact skin
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: 1st reading 0.5h after 24h dosing. no reading at 48 h.
Irritation parameter:
edema score
Basis:
animal #5
Remarks:
intact skin
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: 1st reading 0.5h after 24h dosing. no reading at 48 h.
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: 1st reading 0.5h after 24h dosing. no reading at 48 h.
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Score:
3.13
Max. score:
8
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (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:
15 - 18 August 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: 16 CFR 1500.42
GLP compliance:
yes
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:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: not rinsed
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: not rinsed
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: not rinsed
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: not rinsed
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: not rinsed
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: not rinsed
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: not rinsed
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: not rinsed
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: not rinsed
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: not rinsed
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: not rinsed
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: not rinsed
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.3
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: not rinsed
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: not rinsed
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: not rinsed
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2.3
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: no rinsed
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: not rinsed
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2.7
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: not rinsed
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3.7
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: not rinsed
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
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:
animal #3
Time point:
24/48/72 h
Score:
2.7
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: not rinsed
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
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:
animal #5
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: not rinsed
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2.7
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: not rinsed
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Based on the results of this study, the test article is a primary eye irritant according to 16 CFR 1500.
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 (1985)]. 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. It is anticipated that the effects would be reversed in a 14 -day observation period. 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 (1985)]. 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. It is anticipated that the effects would be reversed in a 21 -day observation period. On the basis of these results, the substance is classified as a Category 2 eye irritant.

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 eye irritation study.