Registration Dossier
Registration Dossier
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EC number: 204-798-3 | CAS number: 126-71-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to 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)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Triisobutyl phosphate
- EC Number:
- 204-798-3
- EC Name:
- Triisobutyl phosphate
- Cas Number:
- 126-71-6
- Molecular formula:
- C12H27O4P
- IUPAC Name:
- triisobutyl phosphate
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: Tri-iso-butylphosphat
- Substance type: colorless to slightly yellowish liquid
- Composition of test material, percentage of components: 90% Tri-iso-butylphosphat, 10% n-propanol
- Stability under test conditions: unknown; excluded from statement of compliance
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: SAVO med. Versuchstierzuchten GmbH
- Age at study initiation: males-14 weeks, females-15 weeks
- Weight at study initiation: males 2.4-2.5 kg, females 2.5 kg
- Housing: Individually in stainlesss steel cages equipped with an automatic cleaning and drinking system
- Diet (e.g. ad libitum): Pellet standard Kliba 341, rabbit maintenance diet ad libitum.
- Water (e.g. ad libitum): Community tap water, ad libitum
- Acclimation period: four days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 (+/- 3)
- Humidity (%): 40-70%
- Air changes (per hr):10-15
- Photoperiod (hrs dark / hrs light): 12/12
- Music during light period
IN-LIFE DATES: From: 27/02/1990 To: 06/03/1990
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- Area of coverage: 3 cm x 3 cm
- Type of wrap if used: surgical gauze covered with semi-occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Erythema and Eschar formation: 0 (no erythema)-4 (Severe erythema (beet redness) to slight escar formation (injuries in depth)
Edema formation: 0 (no edema)-4 (severe edema (raised more than 1 mm and extending beyonmd area of exposure)
Maximum cumulative score: -8
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: # 16
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal: # 17
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal: # 18
- Remarks:
- female
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal: # 16
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: # 17
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: # 18
- Remarks:
- female
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- primary irritation score of 0.78 when applied to intact rabbit skin.
local signs (mean 1 hour to 7 days) consisted of grade 0.67 eythema and grade 0.00 edema. Reversible until day 7 of test.
No corrosive effect was evident on the skin
The bodyweight gain was similar for all rabbits
No clinical symptoms or morality during test period
Applicant's summary and conclusion
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