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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
From 02 to 24 August 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study run to a method comparable with current guidelines and to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
5-bromo-3-[(1R)-1-(2,6-dichloro-3-fluorophenyl)ethoxy]pyridin-2-amine
EC Number:
700-798-7
Cas Number:
877399-00-3
Molecular formula:
C13H10BrCl2FN2O
IUPAC Name:
5-bromo-3-[(1R)-1-(2,6-dichloro-3-fluorophenyl)ethoxy]pyridin-2-amine
Details on test material:
- Purity: 99.7% area (HPLC)
- Batch No.: E010010557

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: between 10-20 weeks old
- Weight at study initiation: 2-4 kg
- Housing: labeled cages with perforated floors and shelters
- Diet (e.g. ad libitum): pelleted diet approximately 100 grams per day, hay was provided at least three times a week
- Water (e.g. ad libitum): free access to tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0±3.0℃ (actual range: 19.2-20.3℃)
- Humidity (%): 40-70% (actual range: 46-82%)
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours darkness per day

IN-LIFE DATES: From: 2010-08-02 To: 2010-08-24

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 98.3 mg (range 95.3-103.8 mg) (a volume of approximately 0.1 mL)
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 males
Details on study design:
Immediately after the 24-hour observation, a solution of 2% fluorescein (Merck, Darmstadt, Germany) in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage. Any bright green stained area, indicating epithelial damage, was estimated as a percentage of the total corneal area.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: Mean of 24, 48 and 72 hours
Score:
ca. 0.89
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: fully reversible within 72 hours in two animals and within 7 days in the other animal
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: Mean of 24, 48 and 72 hours
Score:
ca. 0.67
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: fully reversible within 48 hours in all of 3 animals
Irritant / corrosive response data:
Instillation of approximately 98 mg of the test substance into one eye of each of three rabbits resulted in irritation of the conjunctivae, which consisted of redness, chemosis and discharge. The irritation had completely resolved within 72 hours in two animals and within 7 days in the other animal.

No iridial irritation or corneal opacity was observed, and treatment of the eyes with 2% fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage.
Other effects:
Remnants of the test substance were present in the eye of two animals on Day 1.

Any other information on results incl. tables

No symptoms of systemic toxicity were observed in the animals during test period and no mortality occurred.

Animal

Time after dosing

 

 

Cornea

(0-4)

Iris

(0-2)

Conjunctivae

Redness

(0-3)

Chemosis

(0-4)

Discharge

(0-3)

462

1 hour

24 hours

48 hours

72 hours

0

0

0

0

0

0

0

0

1

1

1

0

1

1

0

0

1

1

0

0

470

1 hour

24 hours

48 hours

72 hours

7 days

0

0

0

0

0

0

0

0

0

0

1

2

1

1

0

1

1

0

0

0

1

1

0

0

0

471

1 hour

24 hours

48 hours

72 hours

7 days

0

0

0

0

0

0

0

0

0

0

2

1

1

0

0

1

0

0

0

0

1

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Treatment of the test substance caused reversible effects on conjunctivae of all the three rabbits.