Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10-Jul-2009 to 20-Jul-2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This study has been performed in compliance with the Swiss Ordinance relating to Good Laboratory Practice, adopted May 18th, 2005 [SR 813.112.1]. This Ordinance is based on the OECD Principles of Good Laboratory Practice, as revised in 1997 and adopted November 26th, 1997 by decision of the OECD Council [C(97)186/Final]. These principles are compatible with Good Laboratory Practice regulations specified by regulatory authorities throughout the European Community, the United States (EPA and FDA), and Japan (MHLW, MAFF and METI).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
-

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan France ZI Le Malcourlet 03800 Gannat / France
- Age at study initiation: males: 16 weeks, females 16 weeks
- Weight at study initiation: male: 2327 g, females 2509 and 2725 g
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks (Harlan Laboratories Ltd., Füllinsdorf) and haysticks 4642 (batch no. 69/08, Provimi Kliba AG) were provided for gnawing.
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 27/09) provided by Provimi Kliba AG, 4303 Kaiseraugst / Switzerland.
- Water (e.g. ad libitum):Community tap water from Füllinsdorf ad libitum.
- Acclimation period: 10-Jul-2009 to 14-Jul-2009


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark


IN-LIFE DATES: From: 15-Jul-2009 To: 20-Jul-2009

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL/animal
Duration of treatment / exposure:
single instillation
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
1 male
2 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
Washing (if done): no washing done


SCORING SYSTEM: according to the numerical scoring system listed in the Commission Regulation (EC) No 440/2008, B.5.
Data were summarized in tabular form, showing for each individual animal the irritation scores for the designated observation time, a description of the degree and nature of irritation, the presence of serious lesions and non-ocular effects. The scores of each animal at the following reading times (24, 48, 72 hours) were used in calculating the respective mean values (with the exception of the sclerae) for each type of lesion.


TOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic-lamp (Roth AG, 4153 Reinach / Switzerland)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: mean cores for animal numbers 84, 85 and 86
Time point:
other: mean value of scores at 24, 48 and 72 hours after instillation
Score:
0
Max. score:
4
Reversibility:
other: No effects observed
Remarks on result:
other: individual mean score: 0 -0 -0
Irritation parameter:
iris score
Basis:
other: mean scores for animal numbers 84, 85 and 86
Time point:
other: mean value of scores at 24, 48 and 72hours after instillation
Score:
0
Max. score:
2
Reversibility:
other: no effects observed
Remarks on result:
other: individual mean scores: 0 - 0 -0
Irritation parameter:
conjunctivae score
Basis:
other: mean scores for animal numbers 84, 85 and 86
Time point:
other: mean value of scores at 24, 48 and 72 hours after instillation
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: individual mean scores: 0 - 0 -0
Irritation parameter:
chemosis score
Basis:
other: mean scores for animal numbers 84, 85 and 86
Time point:
other: mean value of scores at 24, 48 and 72 hours after instillation
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: individual mean scores: 0 - 0 -0
Irritant / corrosive response data:
The test item did not induce significant or irreversible damage to the rabbit eye.
Other effects:
No staining produced by the test item of the treated eye was observed.
Slight scleral reddening noted in the male and one female at the 1-hour reading. The slight scleral reddening persisted up to the 24- (the male) or
the 48-hour reading (one female).

Any other information on results incl. tables

The instillation of TRIQUAT Monomer into the eye resulted in mild, early-onset and transient ocular changes, such as conjunctival and scleral reddening as well as conjunctival chemosis in the male and one female. The conjunctival effects were no longer evident from 24 hours after treatment. The scleral reddening persisted in both animals at the 24 hours and in one of the two animals at the 48 hours. No abnormal findings were observed in the cornea or iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed and no clinical signs were observed. One female was devoid of any local signs at any observation time. (see attached table 1)

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based upon the referred classification criteria (Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labeling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and
amending Regulation (EC) No 1907/2006), TRIQUAT Monomer is considered to be “not irritating” to the rabbit eye.
Executive summary:

The primary eye irritation potential of TRIQUAT Monomer was investigated according to OECD test guideline no. 405. The test item was applied by instillation of 0.1 mL into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test item instillation.

The instillation of TRIQUAT Monomer into the eye resulted in mild, early-onset and transient ocular changes, such as conjunctival and scleral reddening as well as conjunctival chemosis in the male and one female.The conjunctival effects were no longer evident from 24 hours after treatment. The scleral reddening persisted in both animals at the 24 hours and in one of the two animals at the 48 hours. No abnormal findings were observed in the cornea or iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed and no clinical signs were observed. One female was devoid of any local signs at any observation time.

Thus, the test item did not induce significant or irreversible damage to the rabbit eye.

The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for the conjunctival reddening and chemosis were 0.00 for each of the

three animals.