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EC number: 807-935-0 | CAS number: 1244733-77-4
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:
- other: Guideline study.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
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:
- 1-chloropropan-2-yl bis(2-chloropropyl) phosphate; bis(1-chloropropan-2-yl) 2-chloropropyl phosphate; tris(1-chloropropan-2-yl) phosphate; tris(2-chloropropyl) phosphate
- EC Number:
- 807-935-0
- Cas Number:
- 1244733-77-4
- Molecular formula:
- C9H18Cl3O4P
- IUPAC Name:
- 1-chloropropan-2-yl bis(2-chloropropyl) phosphate; bis(1-chloropropan-2-yl) 2-chloropropyl phosphate; tris(1-chloropropan-2-yl) phosphate; tris(2-chloropropyl) phosphate
- 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
Constituent 1
- 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 or test system 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 | o | e | o | e | o | e | o | e | o | e | o | e | o | ||
| 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 | - | - | 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.
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