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Description of key information

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 based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
From February 16,1988 to March 02, 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
KL2 due to RA
Justification for type of information:
Refer to the section 13 for details on the category justification.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
no
Species:
rabbit
Strain:
other: Small White Russian
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.2 - 2.7 kg
- Housing: steel cages
- Diet (e.g. ad libitum): K4 diet for rabbit, Ssniff Special Diets, Soet, Germany
- Water (e.g. ad libitum): tap water

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-1°C
- Humidity (%): 60 +/- 5%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light):12/12
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of product with 0.5 cm3 water
Duration of treatment / exposure:
4 h
Observation period:
14 d
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: exposure site covered with 2.5 x 2.5 cm patch. 6 x 6 cm Polyethylene wrapping placed on top and fixed with an elastic band.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing with warm water directly after patch removal.
- Time after start of exposure: 4 h


SCORING SYSTEM: OECD 404 method
Irritation parameter:
erythema score
Basis:
animal: 1 to 3
Time point:
24 h
Score:
>= 2 - <= 3
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
erythema score
Basis:
animal: 1 to 3
Time point:
48 h
Score:
>= 2 - <= 3
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
erythema score
Basis:
animal: 1 to 3
Time point:
72 h
Max. score:
4
Reversibility:
fully reversible within: 14 d
Remarks on result:
other: Spotty skin reaction (grade 2 or 3)
Irritation parameter:
erythema score
Basis:
animal: 1 to 3
Time point:
other: 6 to 10 d
Max. score:
4
Reversibility:
fully reversible within: 14 d
Remarks on result:
other: eschar and detaching
Irritation parameter:
erythema score
Basis:
animal: 1 to 3
Time point:
14 d
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: 1 to 3
Time point:
24/48/72 h
Score:
>= 1 - <= 2
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
edema score
Basis:
animal: 1 to 3
Time point:
14 d
Score:
0
Max. score:
4
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
14 d
Score:
3.67
Max. score:
8
Reversibility:
fully reversible within: 14 days

Table 1: Skin irritation responses in rabbit exposed to test substance

 Animal N°  1 h        24 h    48 h    72 h      6 d 8 d     10 d    

   14 d

 S  R
 2  1  2  1  2  1  x2  1  Sc SciA 0 0 0  0
2  2  2  3  1  2  1  x2  1  Sc  SciA  SciA 0  0
3  2  3  3  2  3  1  x3  1 Sc SciA  SciA 0  0

R: redness (erythema); S: swelling (oedema); x: spotty skin reaction; Sc: eschar; iA: detaching

Absolute average

4,00 4,00 3,33 3,33 => 14.66/4 = 3.67

Assessment according to Appendix VI of Directive 79/831/EC:

Redness (erythema): average = 2.44

Swelling (oedema): average = 1.11

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Under the study conditions, the test substance was considered to be moderately irritating to rabbit skin.
Executive summary:

A study was conducted to assess the skin irritation potential of the read across substance, C8-18 and C18-unsatd. MEA, in rabbits according to OECD Guideline 404. The substance was applied in water to the shaved skin of three Small White Russian rabbits using an occlusive bandage. After 4 h, the exposed skin was rinsed, then observed for 14 d. Redness (erythema), swelling (oedema) and eschar formation was apparent in all animals. The effects were reversible within 14 d. The overall irritation index was 3.67 (on a total possible of 8). Under the study conditions, the read across substance was considered to be moderately irritating to rabbit skin (Mürmann, 1988).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

A study was conducted to assess the skin irritation potential of the read across substance, C8-18 and C18-unsatd. MEA, in rabbits according to OECD Guideline 404. The substance was applied in water to the shaved skin of three Small White Russian rabbits using an occlusive bandage. After 4 h, the exposed skin was rinsed, then observed for 14 d. Redness (erythema), swelling (oedema) and eschar formation was apparent in all animals. The effects were reversible within 14 d. The overall irritation index was 3.67 (on a total possible of 8). Under the study conditions, the read across substance was considered to be moderately irritating to rabbit skin (Mürmann, 1988).

Eye irritation

A study was conducted to assess the eye irritation potential of the read across substance, C8-18 and C18-unsatd. MEA, in rabbits according to OECD Guideline 405. Ground neat read across substance (0.1 g) was placed in the lid of the right eye of each Small White Russian rabbit. Seventy-two h after application, the treated eyes were analysed for corneal damage using a Na-fluorescein solution, then rinsed with warm physiological solution. Effects were evaluated at 1, 24, 48 and 72 h, as well as at 6, 8, 10, 13, 17 and 21 d after application, according to Draize (1959). Damage to the cornea and iris of one animal was still present after 21 d. This was considered irreversible. The mean overall score was 26.8 (maximum possible: 110). Under the study conditions, the read across substance was considered to be highly irritating to rabbit eyes (Mürmann, 1988).

Justification for classification or non-classification

Skin

The key in vivo skin irritation study conducted with the read-across substance, C8-18 and C18-unsatd. MEA, demonstrated that a 4 h occlusive exposure was irritating to skin. On the basis of this study, the substance was classified as Skin Irrit. 2 - H315 (causes skin irritation) according to CLP (EC 1272/2008) criteria. 

Eye

The key in vivo eye irritation study suggests that the read across substance, C8-18 and C18-unsatd. MEA, is highly irritating to eyes, with irreversible eye effects in one animal. Since the effects seen in this study were severe, the substance was classified as Eye Damage 1 - H318 (causes serious eye damage) according to CLP (EC 1272/2008) criteria.