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EC number: 273-086-2 | CAS number: 68937-75-7
Toxicological information
Skin irritation / corrosion
Currently viewing:
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 Nov - 13 Dec 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted May 1981
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Fatty acids, C8-10
- EC Number:
- 273-086-2
- EC Name:
- Fatty acids, C8-10
- Cas Number:
- 68937-75-7
- Molecular formula:
- not availbale (UVCB substance)
- IUPAC Name:
- Fatty acids, C8-10 (even numbered)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld, Germany
- Age at study initiation: approx. 14 weeks
- Weight at study initiation: 2884 - 3069 g
- Housing: individually in cages with perforated floors equipped with an automatic drinking system (ITL, Bergen, The Netherlands)
- Diet: standard laboratory diet (LKK-20, pellet diameter 4 mm, Hope Farms, Woerden, The Netherlands) approx. 100 g per day
- Water: free access to tap water diluted with decalcified water
- Acclimation period: at least five days under test conditions
ENVIRONMENTAL CONDITIONS
Standard Laboratory Conditions
- Temperature (°C): 21 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin sites of same animals
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 21 days
Reading time points: 1, 24, 48 and 72 h and 7, 14 and 21 days - Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: dorsal skin
- Site preparation: approximately 24 hours before treatment, the dorsal fur was shaved with an electric clipper, exposing an area of approximately 100 square centimetres (10 cm x 10 cm). Prior to test substance administration, the animals were physically examined and the skin. found to be intact and normal.
- Type of wrap if used: surgical gauze patch 2x3 cm mounted on Micropore tape (3M, U.S.A.). The dressing was wrapped around the abdomen and secured with an elastic bandage (Coban, 3M, U.S.A.)
REMOVAL OF TEST SUBSTANCE
- Washing: tissue moistened with tap-water and subsequently a dry tissue
- Time after start of exposure: 4 h
SCORING SYSTEM:
In order to facilitate the scoring, the skin area concerned of all animals was shaved again before the observation on days 2, 3, 4, 8, 15 and 22.
Scoring acc. to Draize (1994):
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 deep)
Edema:
0 - no edema
1- very slight edema (barely perceptible)
2 - slight edema (edges of area well defined by definite raising)
3 - moderate edema (raised appr. 1 mm)
4 - severe edema (raised >1 mm and extending beyond area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: edema could not be scored after 48 and 72 h due to eschar formation; 48 and 72 h scores were assumed to be the same as at 24 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: mean value could not be calculated for animal #2 due to the omission of edema scores due to eschar formation at 24, 48 and 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- The observed skin irritation consisted of eschar formation and slight to moderate edema.
The irritation was reversible within 14 days after exposure in animal #3, within 21 days after exposure in animal #1, but had not resolved by day 22 in animal #2. Animal #2 showed new skin formation with very slight erythema and slight edema on day 22. No corrosive effect was evident on the skin. - Other effects:
- In the area of application brown staining of the treated skin by the test substance and adherence of the test article was observed. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Any other information on results incl. tables
Readings:
| Time | Animal | Erythema | Edema | Additional findings |
| 1 h | 1 | 2 | 2 | b |
| 2 | 2 | 2 | b | |
| 3 | 2 | 2 | b | |
| 24 h | 1 | 4 | 3 | eschar formation |
| 2 | 4 | - | n | |
| 3 | 3 | 3 | - | |
| 48 h | 1 | 4 | - | n |
| 2 | 4 | - | n | |
| 3 | 4 | 3 | ± 5% eschar formtation | |
| 72 h | 1 | 4 | - | n |
| 2 | 4 | - | n | |
| 3 | 4 | 3 | ± 50% eschar formation | |
| 7 d | 1 | 4 | - | n |
| 2 | 4 | - | n | |
| 3 | 1 | 1 | ± 50% new skin formation | |
| 14 d | 1 | 1 | 1 | ± 50% new skin formation |
| 2 | 1 | 1 | new skin formation | |
| 3 | 0 | 0 | scaliness | |
| 21 d | 1 | 0 | 0 | ± 25% new skin formation |
| 2 | 1 | 2 | ± 50% new skin formation | |
| 3 | 0 | 0 | - | |
| mean 24 - 48 - 72 h | 1 | 4 | 3 | |
| 2 | 4 | - | ||
| 3 | 3.7 | 3 | ||
| mean | 3.9 | 3 | ||
b: brown test substance adhered to skin
n: edema could not be scored due to eschar formation
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin Irrit. 2, H315 according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: Skin Irrit. 2, H315
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