Registration Dossier

Administrative data

Endpoint:
pH
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002-06-13 - 2002-07-22
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-reference
Reason / purpose:
reference to same study
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002-06-13 - 2002-07-22
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)
Remarks:
2000-04-26
Specific details on test material used for the study:
- Synonyms: ITC 908, vinylidenephosphonic acid tetrasodium salt (VDPA tetrasodium salt)
- Lot/batch No.of test material: 562CH/646
- Purity: 87.33%
- Storage condition of test material: Room temperature, in the dark
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-20 weeks old
- Weight at study initiation: 2.0 - 3.53 kg
- Housing: Individually housed in suspended metal cages
- Diet: Certified Rabbit Diet supplied by PMI Nutrition International, Nottingham, UK and IPS Product Supplies Limited, Northants, UK
- Water: ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 ml (79 mg)

(Initially a single rabbit was treated. After consideration of the response of the first animal, two additional animals were treated and in order to minimise pain on application one drop of local anaesthetic was installed 1 to 2 minutes before treatment.)
Duration of treatment / exposure:
No washing
Observation period (in vivo):
1, 24, 48 and 72 hours, 7, 14 and 21 days
Number of animals or in vitro replicates:
3
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.66
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Reversibility:
fully reversible within: 21 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Reversibility:
fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
Dulling of the normal lustre of the cornea was noted in two treated eyes one hour after treatment. Scattered or diffuse corneal opacity was used in two treated eyes at the 24-hour observation. Scattered or diffuse corneal opacity persisted in one treated eye at the 48-hour observation with translucent corneal opacity at the 72-hour observation and scattered or diffuse corneal opacity at the 7 and 14-day observations. Vascularisation, localised ingrowth of vessels for 2 mm to 3 mm, was noted in one treated eye at the 7 and 14-day obervations.

Iridial inflammation was noted in one treated eye one hour after treatment and in two treated eyes at the 24 and 48-hour observations and persisted in one treated eye at the 72-hour observation.

Moderate conjunctival irritation was noted in all treated eyes one hour after treatment and at the 24, 48 and 72-hour observations. Moderate conjunctival irritation was noted in one treated eye with minimal conjunctival irritation in two treated eyes at the 7-day observation. Minimal conjunctival irritation was noted in one treated eye at the 14-day observation.

Petechial haemorrhage scattered over the nicitating membrane was noted in one treated eye one hour after treatment and at the 24 and 48-hour observations and in two treated eyes at the 72-hour and 7-day observations.

Two treated eyes appeared normal at the 14-day observation and one treated eye appeared normal at the 21-day observation.
Interpretation of results:
Category 2A (irritating to eyes) based on GHS criteria
Conclusions:
The test material was irritating to the eyes of rabbits but all effects were reversible within 21 days.
Executive summary:

According to the Regulation (EC) No 1272/2008, VDPA Tetra Sodium Salt should be classified as Irritating to eyes (Category 2A).

The test material was irritating to the eyes of rabbits but all effects were reversible within 21 days.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Exact method to measure the pH is not indicated
GLP compliance:
yes (incl. certificate)
Remarks:
2000-04-26

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
- Synonyms: ITC 908, vinylidenephosphonic acid tetrasodium salt (VDPA tetrasodium salt)
- Lot/batch No.of test material: 562CH/646
- Purity: 87.33%
- Storage condition of test material: Room temperature, in the dark

Results and discussion

pH value
pH value:
ca. 11.7
Concentration:
10 other: % w/w

Applicant's summary and conclusion

Conclusions:
The measured pH of a 10%w/w aqueous solution was 11.7.
Executive summary:

The measured pH of a 10%w/w aqueous solution was 11.7.