Registration Dossier
Registration Dossier
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EC number: 203-350-4 | CAS number: 105-99-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 - 19 Apr 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (adopted 12 May 1981)
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Dibutyl adipate
- EC Number:
- 203-350-4
- EC Name:
- Dibutyl adipate
- Cas Number:
- 105-99-7
- Molecular formula:
- C14H26O4
- IUPAC Name:
- 1,6-dibutyl hexanedioate
- Details on test material:
- - Name of test material: Adipinsäure-di-n-butylester
- Physical state: clear liquid
- Analytical purity: approx. 99.7%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Small White Russian,Chbb‐SPF
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.1 to 2.3 kg (male)
- Housing: Kept individually in stainless steel cages
- Diet: K4 complete feed for rabbits, Ssniff Spezialfutter GmbH, Soest, Germany, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 8 days
Reading time points: 1, 24, 48 and 72 h and 6 and 8 days - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm² on the dorsal and lateral area of the trunk
- Type of wrap if used: The treated skin was covered with a 2.5 x 2.5 cm muslin cloth held in place with elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test material was removed with warm water.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: Scaling was observed at Day 6 only
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: eschar formation was seen at Day 6
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritant / corrosive response data:
- At the 1 h reading time point all three animals exhibited slight to obvious erythemas (grade 2) and very slight edema (grade 1). After 6‐8 days all animals had no symptoms.
- Other effects:
- In one rabbit scaling was evident at the treatment side after 6 days. Another rabbit exhibited eschar formation at the treatment site after 6 days. Both effects were fully reversible within 8 days.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: Xi, R38
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