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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:
other: Guideline study.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991

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
Test material form:
liquid
Details on test material:
Tris chloroisopropyl phosphate
Purity: 97.85% including all isomers

name: tris-chloroisopropylphosphate
manufacturer: Bayer AG (now LANXESS)
sample no: 002871/1989
content: 97.85% analytical date 8 Aug 1990
expiry date: 13 Dec 1991
appearance: clear liquid
storage: room temperature
MW: 327.6
Molecular formula:C9H18Cl3O4P
CAS no: 13674-84-5
intended use: industrial chemical
Specific details on test material used for the study:
IUCLID4 Test substance: other TS

TS-Freetext:
Tris chloroisopropyl phosphate purity 97.85% including all
isomers as per 1.1 - 1.4.

- Name of test material (as cited in study report): Tris-chlorisopropylphosphat
- Molecular formula (if other than submission substance): C9H18Cl3O4P
- Molecular weight (if other than submission substance): 327.6
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type:
- Physical state: colourless clear liquid
- Analytical purity: 97.85%
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.: 002871/1989 of 13.12.1989 production process sample
- Expiration date of the lot/batch:
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions: guarenteed for test period
- Storage condition of test material: room temperature in dark
- Other: pH 3.7

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK Ltd, Huntingdon
- Age at study initiation: not given
- Weight at study initiation: 3.4-3.5 kg
- Housing:individually in stainless steel or plastic cages
- Diet (e.g. ad libitum): Standard diet Ssniff K 4 100-120 g/day
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period:at least 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-3C
- Humidity (%): apprx 50%
- Air changes (per hr): 10 per hour
- Photoperiod (hrs dark / hrs light):12 hours light/dark cycle


IN-LIFE DATES: From:8-January-1991 To:15 January 1991

Test system

Type of coverage:
semiocclusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
other: treated animals served also as control
Amount / concentration applied:
A volume of 0.5 ml of the test material was applied via a patch to the shaved skin (6cm2) of each of three rabbits. A further patch, moistened with water was also applied on the opposite shaved dorso-lateral area of the trunk.
Duration of treatment / exposure:
After an exposure period of 4 hours, patches and dressing were removed and the treated sites were carefully washed with water.
Observation period:
Dermal irritation was scored (following the OECD recommended scoring system) and recorded at termination of exposure as well as 1 hr, 24 hrs, 48 hrs, 72 hrs, 7 days and 14 days after exposure.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- % coverage:
- Type of wrap if used: Hansamed patch held in place with Fixonmull semiocclusive dressing Beiersdorf


REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with water
- Time after start of exposure: 4 hrs


SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
The test substance did not cause oedema formation in any of the animals (primary irritation score 0). Well-defined erythema (score 2) was evident at the test site of two rabbits 1 hour after termination of exposure but by 24 hrs only slight erythema was evident (score 1) and all evidence of erythema formation had disappeared by 48 hrs. In the other rabbit, slight erythema was observed at 1 hr but had disappeared by 24 hrs. The mean skin irritation index for each of the two most sensitive rabbits was 0.3. TCPP therefore does not have a local irritant potential in the rabbit skin.
Other effects:
no data

Any other information on results incl. tables

Test for irritant effect on the skin (expos.: 4hrs)

 Animal No.:  Body weight  Draize grade after                                 Irritat.Index    
     1h     24h     48h     72h     7d     14d        
     e  e  o  e  o  e  o  e  e  o  e
 M20  3,4 kg (female)  2  0  1  0  0  0  0  0  0  0  -  -  0,3*  0,0
 M25  3,4 kg (female)  1  0  0  0  0  0  0  0  0  0  -  -  0,0  0,0
 M8  3,5 kg (female)  2  0  1  0  0  0  0  0  0  -  -  0,3*  0,0

e = erythema and eschar formation

o = oedema formation

- = not examined

* 0,3 = no irritation (irritation index 0,0 to 0,99)

Applicant's summary and conclusion

Executive summary:

The irritant/corrosive potential of the test substance TCPP was studied on the skin of the rabbit in accordance with the OECD Guideline No. 404 for testing of Chemicals.

The results of this experiment indicate that the test substance is not irritating to the skin.

The substance does not have a significant local irritating potential to the skin.