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Administrative data

Description of key information

The test substance was assessed for skin irritation according to EC Method B4 and eye irritation according to EC method B5.  The test substance was shown to be irritating to both skin and eyes.

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:
1993-12-07 to 1993-12-17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes
Remarks:
no certificate
Specific details on test material used for the study:
- Name of test material (as cited in study report): Aldehyde C10
- Substance type: Clear liquid
- Physical state: Liquid
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Batch No: 93/10/02
- Expiration date of the lot/batch: 1994-04
- Stability under test conditions: No data
- Storage condition of test material: No data
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Froxfield (UK) Ltd, Petersfield, Hampshire, United Kingdom
- Age at study initiation: 11 to 13 wks
- Weight at study initiation: 2.6 to 3.1 kg
- Housing: Individually in cages with perforated floors
- Diet: standard laboratory diet SDS Stanrab (P) rabbit diet ad libitum (not analysed)
- Water: Ad libitum
- Acclimation period: Yes

ENVIRONMENTAL CONDITIONS
- Temperature: Approx. 19 °C
- Humidity: 30 to 70 %
- Air changes: Approx. 19 per hr
- Photoperiod: 12 hrs dark / 12 hrs light
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Volume applied: 0.5 mL
Duration of treatment / exposure:
4 hr
Observation period:
11 d
Number of animals:
3
Details on study design:
TEST SITE
- 24 hr prior to application, approx. 100 mm x 100 mm site on dorso-lumbar region clipped with electric clippers.
- Test substance applied under a 25 mm x 25 mm gauze pad to 1 intact skin site on each animal.
- Each site covered with an Elastoplast elastic adhesive dressing for 4 hrs.
- The animals were not restrained during the exposure period and were returned to their cages immediately after treatment.

REMOVAL OF TEST SUBSTANCE
- Washing at end of exposure period with warm water (30 to 40 °C) to remove any residual test substance. Test area then blotted dry with absorbant paper.

SCORING SYSTEM:
- Erythema
-- 0: No erythema
-- 1: Very slight erythema (barely perceptible)
-- 2: Well-defined erythema
-- 3: Moderate to severe erythema
-- 4: Severe erythema (beet redness) to slight eschar formation (injuries in depth) preventing erythema reading
- Oedema:
-- 0: No oedema
-- 1: Very slight oedema (barely perceptible)
-- 2: Slight oedema (edges of area well-defined by definite raising)
-- 3: Moderate oedema (raised approximately 1 mm)
-- 4: Severe oedema (raised more than 1 mm and extending beyond the area of exposure)
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: Mean of scores at 24, 48 and 72 h
Score:
2
Reversibility:
fully reversible within: 11 d
Remarks on result:
other: Desquamation observed on days 7-10
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: Mean of scores at 24, 48 and 72 h
Score:
1.33
Reversibility:
fully reversible within: 11 d
Remarks on result:
other: Blanching observed on days 8 and 8. Hardening of the skin observed on day 9. Desquamation observed on day 10
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: Mean of scores at 24, 48 and 72 h
Score:
3
Reversibility:
fully reversible within: 11 d
Remarks on result:
other: Desquamation observed on days 7-10
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: Mean of scores at 24, 48 and 72 h
Score:
1
Reversibility:
fully reversible within: 11 d
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: Mean of scores at 24, 48 and 72 h
Score:
1
Remarks on result:
other: Hardening of the skin observed on day 10
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: Mean of scores at 24, 48 and 72h
Score:
2
Reversibility:
fully reversible within: 11 d
Irritant / corrosive response data:
The numerical values given to the dermal reactions elicited by Aldehyde C10 are shown in Table 1.

Well-defined to moderate erythema with very slight or slight oedema developed in all three animals. In two animals these reactions were accompanied by desquamation of the stratum corneum from Day 7. Blanching, hardening of the skin and desquamation of the stratum corneum was seen in the third animal. The reactions gradually ameliorated and had resolved completely by day 11.

Table 1: Dermal reactions observed after application of Aldehyde C10

Rabbit number and sex

E = Erythema

O = Oedema

Day

1

2

3

4

5

6

7

8

9

10

11

2801

E

O

1

0

2

1

2

1

2

1

2

1

2

1

a2

1

a2

1

a1

1

a1

1

0

0

2802

E

O

1

0

2

1

1

1

1

1

2

1

2

1

b3

`1

b2

1

c1

1

a1

c1

0

0

2803

E

O

2

1

2

2

2

2

2

2

3

2

2

2

a2

2

a2

2

a1

1

a1

1

0

0

* Approximately 30 minutes after removal of the dressing

a Desquamation of the startum corneum

b Blanching

c Hardening of the skin

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was assessed for skin irritation according to OECD EU Method B.4. Under the conditions of the test, the test substance was not shown as irritating and therefore is not considered to be classified as irritating to skin according to CLP Regulation No (EC) 1272/2008.
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:
1993-12-20 to 1994-01-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): Aldehyde C10
- Substance type: Clear liquid
- Physical state: Liquid
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Batch No: 93/10/02
- Expiration date of the batch: 1994-04
- Stability under test conditions: No data
- Storage condition of test material: Room temperature in the dark
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Froxfield (UK) Ltd, Petersfield, Hampshire, United Kingdom
- Age at study initiation: Approx. 12 to 15 wks
- Weight at study initiation: 2.8 to 3.6 kg
- Housing: Individually in plastic cages with perforated floors
- Diet: SDS Stanrab (P) rabbit diet ad libitum (not analysed)
- Water: Ad libitum
- Acclimation period: Yes, details unclear

ENVIRONMENTAL CONDITIONS
- Temperature: Approx 19 °C
- Humidity: 30 to 70 %
- Air changes: Approx 19 per hr
- Photoperiod: (12 hrs dark / 12 hrs light)
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Volume applied: 0.1 mL
Duration of treatment / exposure:
Single exposure
Observation period (in vivo):
14 d (observations at 1 hr, 24 hr, 48 hr, 72 hr, 4d, 7d, 14 d).
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM:
- Please refer to attached supporting information

TOOL USED TO ASSESS SCORE: hand-held light

CLINICAL SIGNS
- All animals were observed daily for signs of ill health or toxicity.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: Mean of scores at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: Mean of scores at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: Mean of scores at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: Mean of scores at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: Mean of scores at 24, 48 and 72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: Mean of scores at 24 48 and 72 h,
Score:
2
Reversibility:
fully reversible
Remarks:
7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
other: Mean of scores at 24, 48 and 72 h
Score:
2
Reversibility:
fully reversible
Remarks:
14 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
other: Mean of scores at 24, 48 and 72 h
Score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: Mean of scores at 24, 48 and 72 h
Score:
1.33
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: Mean of scores at 24, 48 and 72 h
Score:
2.33
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: Mean of scores at 24, 48 and 72 h
Score:
2
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
- Dulling of the cornea was seen in 1 animal 1 hr after installation only
- No iridial inflammation was observed
- A diffuse crimson colouration of the conjunctivae was observed in all 3 animals, accompanied by swelling with partial eversion of the eyelids about half closed.
- The eyes were normal 7 or 14 d after instillation
- The results table from the study report is attached as background material.
Other effects:
Clinical signs: There were no signs of toxicity or ill health in any rabbit during the observation period.
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The test substance was assessed for eye irritation according to EU Method B.5. Under the conditions of the test, the test substance caused irritation and should be classified as irritating to eyes (Category 2) according to CLP Regulation No (EC) 1272/2008.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

The key study was performed according to GLP and EC Method B.4. Three rabbits were each administered a single dermal dose of 0.5 ml of the test substance and observed for 11 days. A single semi-occlusive application of Aldehyde C10 to intact rabbit skin for four hours elicited well defined to moderate dermal reactions. All reactions had resolved by day 11.

Eye irritation:

The key study was performed according to GLP and EC Method B.5. Three rabbits were each administered a single ocular dose of 0.1 mL of the test substance and observed for 14 days after instillation. A single instillation of Aldehyde C10 into the eye of the rabbit elicited dulling of the cornea and well defined conjunctival irritation. All reactions had resolved 7 or 14 days after instillation.


Justification for selection of skin irritation / corrosion endpoint:
GLP study performed to a guideline on the test substance.

Justification for selection of eye irritation endpoint:
GLP study performed to a guideline on the test substance.

Effects on eye irritation: irritating

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Skin irritation:

On the basis of the results in accordance with the classification criteria set out in CLP Regulation (EC) no. 1272/2008 the test substance is not considered to be classified as a skin irritant.

Eye irritation:

On the basis of the results in accordance with the classification criteria set out in CLP Regulation (EC) no. 1272/2008 the test substance is considered to be classified as Irritating to eyes (Category 2)