Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye 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 405 (Acute Eye 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 / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK Ltd, Huntingdon
- Age at study initiation: not given
- Weight at study initiation: 3.6-3.7 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

Vehicle:
unchanged (no vehicle)
Controls:
other: treated animals served also as control (one eye TCPP, the other remained untreated and served as control)
Amount / concentration applied:
100 µl TCPP in one eye.
Duration of treatment / exposure:
24 h
Observation period (in vivo):
7 d
Number of animals or in vitro replicates:
3 females
Details on study design:
A volume of 0.1 ml of the test material was instilled into the conjunctival sac of one eye of each of three rabbits. The other eye remained untreated and served as control. The treated eyes were rinsed with saline 24 hours post-treatment.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable; observation time 7 days
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
There were no signs of irritation in any of the treated eyes at any of the observation times of 24, 48 and 72 hours. One animal had evidence of aqueous humour discharge at 48 hours, but this did not persist.

Any other information on results incl. tables

Test for irritant effect on the eye (expos.24hrs):

 Animal No.+Body weight  Tissue  Signs  Draize grades                    
M5, female (3,7 kg)    1h  24h  48h  72h  7d  14d  21d   Irritation index
  cornea  o  0 0,0 
     a  0  0  0  
   fluorescein  0  -  -  
   a  0  -  -  -  
   iris    0  0  0  - 0,0 
conjunctivae  r  0 0,0 
     0  0  - 0,0 
  aqueous humour    0  0  
  discharge    1  0 0  0  
L25, female(3,6 kg)   cornea  o  0  0  - 0,0 
   0  0  
  fluorescein   i  -  -  
     a  -  0  -  
  iris    0,0 
   conjunctivae  r 0,0 
     0  - 0,0 
   aqueous humour    0  0  0  -  -  
  discharge     0  0  
       1  0  
 L14, female(3,7 kg)  cornea  o  0 0,0 
     a 0  0  0  
  fluorescein   i  -  -  
     a  -  -  
  iris     0  0 0,0 
  conjunctivae   - 0,0 
     0 0,0 
  aqueous humour     -  
   discharge    1  0  0  0  0  -  -  

o = opacity

a = area

i = intensity

r = redness

s = swelling

- = not examined

Applicant's summary and conclusion

Executive summary:

The irritant/corrosive potential of the test substance TCPP was studied on the eye of the rabbit in accordance with the OECD Guideline No. 405 for testing of Chemicals.

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

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