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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
The study was performed between 26 January 1998 and 4 February 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
UK GLP standards (Schedule 1, Good Laboratory Practice Regulations 1997 (SI 1997/654))

Test material

Constituent 1
Chemical structure
Reference substance name:
4,4'-bis(methoxymethyl)-1,1'-biphenyl
EC Number:
700-008-0
Cas Number:
3753-18-2
Molecular formula:
C16 H18 O2
IUPAC Name:
4,4'-bis(methoxymethyl)-1,1'-biphenyl
Constituent 2
Reference substance name:
4,4-bis(methoxymethyl)-biphenyl
IUPAC Name:
4,4-bis(methoxymethyl)-biphenyl

Test animals / tissue source

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 to 16 weeks
- Weight at study initiation: 2.77 to 3.09 kg
- Housing: Animals housed individually in suspended metal cages.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 20°C
- Humidity (%): 50 to 65%
- Air changes (per hr): approximately 15 changes per hour
- Photoperiod (hrs dark / hrs light): controlled by time switch to give 12 hours continuous light followed by 12 hours continuous darkness


IN-LIFE DATES: From: Day of dosing (Day 0) To: Day of sacrifice (Day 7)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.1 ml, found to weigh approximately 58 mg
- Concentration (if solution): not applicable


VEHICLE
- Amount(s) applied (volume or weight with unit): not applicable
- Concentration (if solution): not applicable
- Lot/batch no. (if required): not applicable
- Purity: not applicable
Duration of treatment / exposure:
7 days
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3: - 1 animal for initial assesment, followed by 2 more animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not stated in report
- Time after start of exposure: not stated in report


SCORING SYSTEM:modified version of the Kay and Calandra system


TOOL USED TO ASSESS SCORE: standard opthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
degree of opacity
Basis:
animal: 33 Female
Time point:
other: Mean of 24, 48 and 72 hrs
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
cornea opacity score
Remarks:
degree of opacity
Basis:
animal: 174 Male
Time point:
other: Mean of 24, 48 and 72 hrs
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Remarks:
degree of opacity
Basis:
animal: 201 Female
Time point:
other: Mean of 24, 28 and 72 hrs
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
iris score
Basis:
animal: 33 Female
Time point:
other: Mean of 24, 48 and 72 hrs
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
iris score
Basis:
animal: 174 Male
Time point:
other: Mean of 24, 48 and 72 hrs
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
iris score
Basis:
animal: 201 Female
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: 33 Female
Time point:
other: Mean of 24, 48 and 72 hrs
Score:
0
Max. score:
0
Reversibility:
other: No effects observed at 24, 48 or 72 hours
Remarks on result:
other: Score of 1 at 1 hour, fully reversed at 24 hrs
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: 174 Male
Time point:
other: Mean of 24, 48 and 72 hours
Score:
1.67
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: 201 Female
Time point:
other: Mean of 24, 48 and 72 hrs
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal: 33 Female
Time point:
other: Mean of 24, 48 and 72 hrs
Score:
0
Max. score:
0
Reversibility:
other: No effects observed at 24, 48 and 72 hrs
Remarks on result:
other: Score of 1 at 1 hr, fully reversed at 24 hrs
Irritation parameter:
chemosis score
Basis:
animal: 174 Male
Time point:
other: Mean of 24, 48 and 72 hrs
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal: 201 Female
Time point:
other: Mean of 24, 48 and 72 hrs
Score:
1.33
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Score of 2 observed at 1 hr
Irritant / corrosive response data:
Diffuse corneal opacity was noted in one treated eye at the 24-hour observation with translucent corneal opacity at the 48-hour observation and diffuse corneal opacity at the 72-hour observation. No other corneal effects were noted.

Iridial inflammation was noted in one treated eye at the 24 and 48-hour observations. no other iridial effects were noted.

Minimal or moderate conjunctival irritation was noted in all treated eyes at the 1-hour observation. Minimal or moderate conjunctival irritation was noted in two treated eyes at the 24-hour observation with minimal conjunctival irritation at the 48-hour observation. Minimal conjunctival redness was noted in one treated eye at the 72-hour observation.

All treated eyes appeared normal at the end of the observation period.
Other effects:
None noted

Any other information on results incl. tables

The test material did not produce positive criteria in any rabbit according to the EU labelling regulations. No symbol and risk phrases are therefore required.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material did not produce positive criteria in any rabbit according to the EU labelling regulations. No symbol and risk phrases are therefore required.
Executive summary:

A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion" (adopted 24 February 1987) and Method B5 of Commisssion Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

The results may be used as a basis for classification and labelling under Annex VI of Council Directive 67/548 EEC (as adapted to technical progress by commisssion Directive 93/21/EEC) relating to the classification, packaging and labelling of dangerous substances.

A single application of the test material to the non-irrigated eye of three rabbits produced translucent corneal opacity, iridial inflammation and minimal to moderate conjunctival irritation. All treated eyes appeared normal at the end of the observation period.

The test material did not produce positive criteria in any rabbit according to the EU labelling regulations. No symbol and risk phrases are therefore required.