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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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