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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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: Well documented and reported study fully adequate for assessment. The study was conducted according to internationally accepted technical guidelines and in compliance with GLP in a recognized contract research organization.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
of 2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
of 2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
of 1998
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Japanese MAFF Test Data for Registration of Agricultural Chemicals, Eye Irritation (2-1-5), 12 Nohsan No. 8147, Agricultural Production Bureau, November 24, 2000.
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
4'-[(diphenoxyphosphoryl)oxy]-[1,1'-biphenyl]-4-yl diphenyl phosphate
EC Number:
700-627-6
Cas Number:
17270-01-8
Molecular formula:
C36H28O8P2
IUPAC Name:
4'-[(diphenoxyphosphoryl)oxy]-[1,1'-biphenyl]-4-yl diphenyl phosphate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS

- Stock supply of healthy adult rabbits
- Number and Sex: 3 females
- Age on day of dosing (Day 1): 39 or 40 weeks
- Weight prior to dosing (Day 1): Minimum 4.04 kg, maximum 4.63 kg
- Housing: Individual housing in plastic cages with peforated floor
- Environmental enrichment: Small soft white untreated wood blocks
- Diet : Standard laboratory rabbit diet (125 g/animal/day). In addition, dietary supplement of hay
replaced by a supplement of wholemeal bread as from 2 days prior to dose instillation.
- Water: Drinking water, ad libitum
- Acclimation period: 20 to 21 weeks prior to study start under laboratory conditions.

Routine analysis of the batch of diet used for nutrients, possible contaminants and microorganisms and of the drinking water were conducted or available at the testing facility.


ENVIRONMENTAL CONDITIONS

Air conditioned animal room set at:
- Temperature (°C): 18 ± 2°C (as an exception on a single day up to 28°C) *
- Relative Humidity (%): 40 to 70% (as an exception on a single day up to 79%) *
- Photoperiod: 12 hrs artificial light per 24 hrs

* The excursion from the target limits of animal room temperature and relative humidity on a single day was transient and had no impact on the wellbeing of the animals, and thus was considered to have had no impact on the study results.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 mL (weighing ca. 98 mg) of the test material was instilled into the conjunctival sac of one eye per rabbit (right eye).
Immediately after instillation upper and lower eyelids were held together for about 1 second to prevent loss of test material.
The contralateral eye (left eye) remained untreated to serve as a control.
Duration of treatment / exposure:
Eyes were not rinsed after treatment with the test substance. Consequently the treatment/exposure period was equivalent to the entire observation period following instillation, which was 72 hours, or lasted until removal of the test material by physiological mechanisms, whichever happened sooner.
Observation period (in vivo):
72 hours post instillation
Number of animals or in vitro replicates:
3
Details on study design:
EYE EVALUATION:

Before treatment start both eyes of each animal were investigated to ensure that there was no pre-existing corneal damage, iridial inflammation or conjunctival irritation.

One animal (the sentinel) was initially treated and in the absence of a severe effect the remaining two animals were committed to the study.

Eyes were evaluated in all animals at approximately 1, 24, 48 and 72 hours after test substance instillation adopting the numerical scoring system listed in Table 1 in the field below. Grades attained at 24, 48 and 72 hours after instillation were included in the mean gradings of ocular lesions and used for evaluation of the necessity of eye irritation/corrosion classification. Additional checks of the animals at appropriate intervals ensured that no severe injury passed unnoticed.

Equipment used for eye evaluation: Ophthalmoscope or pencil beam torch

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
over 3 animals and 3 time points
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: Corneal ulceration or opacity were not evident
Irritation parameter:
other: Area of corneal opacity
Basis:
mean
Remarks:
over 3 animals and 3 time points
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: Corneal ulceration or opacity were not evident
Irritation parameter:
iris score
Basis:
mean
Remarks:
over 3 animals and 3 time points
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: Iridic changes were not evident
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
over 3 animals and 3 time points
Time point:
other: 24, 48, 72 h
Score:
0.1
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Remarks:
mean over 3 time points
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: In addition, score 1 at 1 hour post instillation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Remarks:
mean over 3 time points
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: Score 1 at 1 hour post instillation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Remarks:
mean over 3 time points
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: Score 1 at 1 hour post instillation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
over 3 animals and 3 time points
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: Chemosis was not evident
Irritation parameter:
other: Discharge
Basis:
mean
Remarks:
over 3 animals and 3 time points
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: Discharge was not evident
Remarks on result:
other: Residual test material was seen around the treated eye of one animal (#3) at 1 hour post instillation
Irritant / corrosive response data:
Corneal and iridic lesions, chemosis and conjunctival discharge were not evident throughout the study. Conjunctival redness, grade 1 (injection of conjunctival blood vessels), was seen in all treated eyes at 1 and/or 24 hours after instillation having completely disappeared in two animals by 24 hours after instillation and in the other animal by 48 hours after instillation. Throughout the study no other signs of ocular irritation were evident.
Other effects:
Observation of the animals for defined behavioural criteria led to the conclusion that instillation of the test substance induced practically no or a slight initial pain response. Any other signs, of systemic toxicity or ill health were not evident.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The outcome of the present study does not necessitate any labelling regarding eye irritation according to EU classification rules [DIRECTIVE 67/548/EEC and REGULATION (EC) 1272/2008]. The minor findings noted at 1 and/or 24 hours post instillation are within the category “not irritating to eyes”. They were fully reversible.