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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986.04.22 - 1986.05.06
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented study undertaken to equivalent standard acute irritation guidelines, although not to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Isononyl alcohol
EC Number:
248-471-3
EC Name:
Isononyl alcohol
Cas Number:
27458-94-2
Molecular formula:
C9H20O
IUPAC Name:
3,5,5-trimethylhexan-1-ol
Details on test material:
- Name of test material (as cited in study report): Isononanol
- Physical state: liquid
- Analytical purity: >99%
- Sample-Number: No. 3635-81058

Test animals

Species:
rabbit
Strain:
other: Kleine weisse Russen, Chbb-SPF
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberbach
- Weight at study initiation: 2.6 - 2.8 Kg
- Housing: separately in stainless steel cage
- Diet (e.g. ad libitum): K4 Alleindiät für Kaninchen, Ssniff Spezialfutter GmbH, 4770 Soest, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +- 1°C
- Humidity (%): 60% +-5% (relative)
- Air changes (per hr): 15 times / hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 cm³

Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3 female rabbits.
Details on study design:
TEST SITE
- Area of exposure: app. 6 cm²
- Type of wrap if used: Mullläppchen

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water
- Time after start of exposure: 4h

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hrs
Score:
2.67
Max. score:
3
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: skin dry and cracked with scab formation during Days 6-14
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hrs
Score:
2.67
Max. score:
3
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hrs
Score:
2.67
Max. score:
3
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: new skin with scab formation at edges and sloughing during Day 6-14
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hrs
Score:
2.67
Max. score:
3
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hrs
Score:
2.67
Max. score:
3
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: skin hardened with scab formation at edges, new skin and sloughing during Days 6-14
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hrs
Score:
3.67
Max. score:
4
Reversibility:
not fully reversible within: 14 days

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information
Executive summary:

Isononanol (0.5 ml) was applied to the shaved skin of three rabbits under semi-occluded dressings for 4 hours. Dermal reactions were recorded 1, 24, 48, and 72 hours after removal of the dressings, and on Days 6, 8,10 and 14. The mean score for erythema at 24, 48 and 72 hours was 2.67 for each animal, and for oedema 2.67 for two animals and 3.0 for the third. The skin was dry, cracked and hardened, with scab formation, sloughing and new skin, amongst the three animals, during Days 8 to 14.

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