Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Aug 19 - Dec 16, 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to OECD TG 405.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Fluorphlogopite (Mg3K[AlF2O(SiO3)3])
EC Number:
234-426-5
EC Name:
Fluorphlogopite (Mg3K[AlF2O(SiO3)3])
Cas Number:
12003-38-2
Molecular formula:
AlF2O10Si33Mg
IUPAC Name:
Fluorphlogopite (Mg3K[AlF2O(SiO3)3])

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Kißlegg
- Age at study initiation: 17-18 weeks
- Mean weight at study initiation: 3.68 kg
- Housing: individual
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):19-24 °C
- Humidity (%): 48-84 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 hours

IN-LIFE DATES: From: day 1 to day 8

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
after 24, 48, and 72 hours, then daily up to day 8
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): --
- Time after start of exposure: --

SCORING SYSTEM: Draize

The right eye of each rabbit remained untreated and served as control

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, and 72 hours after treatment
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, and 72 hours after treatment
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, and 72 hours after treatment
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, and 72 hours after treatment
Score:
0
Max. score:
0
Irritant / corrosive response data:
No signs of irritation were observed at the cornea or iris. All animals showed discharge (score 1) and redness of conjunctivae (score 1) one hour after instillation of the test material. In one animal chemosis (score 1) was seen one hour after instillation of the test material. No abnormalities were detected in the untreated eyes.
Other effects:
No signs of clinical toxicity were detected. All animals survived the observation period. The body weight development of the treated rabbits was inconspicuous.

Any other information on results incl. tables

For details see executive summary

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Fluorophlogopite did not show any eye irritating potential under the conditions of this test. According to EU Directive 67/548/EC amended and repealed by EU Regulation No. 1272/2008 and CLP, the test material should not be regarded as an  irritant to the eyes.
Executive summary:

Study design

For the test of primary eye irritation, 0.1 g of the solid test material was applied into the conjunctival sac in the left eye of rabbits. The right eye remained untreated and served as control. The first examination of the eyes followed 1 hour after instillation. The other examinations of the eyes were performed daily for a further 7 days.
The eyes were evaluated according to the DRAIZE scale (1959).

Results

Ocular alterations

No signs of irritation were observed at the cornea or iris. All animals showed discharge (score l) and redness of conjunctivae (score 1) one hour after instillation of the test material. In one animal chemosis (score 1) was seen one hour after instillation of the test material. 24 hours after treatment, no signs of irritation were observed at the conjunctivae of all animals, No abnormalities were detected in the untreated eyes.

Signs of systemic toxicity, body weight, mortality

No signs of systemic toxicity were seen. The body weight development was not different from that of untreated rabbits of the same age. All animals survived the 8-day observation period.

Evaluation of all animals (24/48/72 hours mean score and max score)

Animal No Mean Score Max Score
Cornea Iris Conjunctivae Cornea Iris Conjunctivae
A A A B A A A B
1 0.00 0.00 0.00 0.00 0 0 0 0
1 0.00 0.00 0.00 0.00 0 0 0 0
3 0.00 0.00 0.00 0.00 0 0 0 0


Conclusions

Fluorphlogopite did not show any eye irritating potential under the conditions of this test. According to EU Directive 67/548/EC amended and repealed by EU Regulation No. 1272/2008 and CLP, the test material should not be regarded as an  irritant to the eyes.