Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

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:
guideline study
Justification for type of information:
Data is from study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
other: EWG Directive 84/449/EWG
Principles of method if other than guideline:
Determination of primary eye irritation study test chemical in rabbits.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
IUPAC name:1,4-dibromobutane
Mol. formula: C4H8Br2
Molecular Weight: 215.915
Smiles: C(CCBr)CBr
InChI: 1S/C4H8Br2/c5-3-1-2-4-6/h1-4H2

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Remarks:
KFM (SPF quality)
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG
CH 4414 Fuellinsdorf/ Switzerland
- Age at study initiation: 14-15 weeks
- Weight at study initiation: 2.3-2.7 kg
- Housing:Individually in stainless steel cage eqiipped with an automatic cleaning and drinking system.
- Diet (e.g. ad libitum): Pelleted stardand Kuba 341, Batch 17/86 rabbit maintenance diet
- Water (e.g. ad libitum):Community tap water from ltingen. ab Libitum.
- Acclimation period:Three days under trest conditions after veterinary examination.

ENVIRONMENTAL CONDITIONS
- Temperature (°C):22±3°C
- Humidity (%):relative humidity 40-70 %
- Air changes (per hr): Air-conditioned with 10-15 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light/12 hours dark, music/light period.

IN-LIFE DATES: From: To: 8 August 1986 to 25 August 1986

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml of test chemical was applied per animal.
Duration of treatment / exposure:
No data
Observation period (in vivo):
The eyes of each animal were examined 1, 24, 48 and 72 hours, after administration.
Number of animals or in vitro replicates:
3 animals
1 male and 2 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data available
- Time after start of exposure: No data available

SCORING SYSTEM: No data available

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Results
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No staining of the conjuctiva and cornea and no corrosion was observed in the rabbits.
Other effects:
- Lesions and clinical observations: No data
- Ophthalmoscopic findings: No data
- Histopathological findings: No data
- Effects of rinsing or washing: No data
- Other observations:No data

Any other information on results incl. tables

Table 3: Primary irritation score

Selected observations

Mean scores

1 hr

2.7

24 hrs

1.3

48 hrs

0.3

72 hrs

0.0

 

Table 4: Mean scores per animal

Animal & Sex

Cornea opacity

Iris

Conjunctivae

Redness

Chemosis

415 M

0.0

0.0

0.7

0.3

146 F

0.0

0.0

0.3

0.0

417 F

0.0

0.0

0.0

0.0

Selected observations for mean: 24 hrs, 48 hrs and 72 hrs

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Conclusions:
The test chemical was found to cause a primary irritation score of 1.1 when applied to the rabbit eye mucosa. No sever effects were observed in 72 hours. Thus, the test chemical was considered to be not Irritating to the eyes.
Executive summary:

An eye irritation study was performed on 1 male and 2 female New Zealand White KFM (SPF quality) rabbits. The test chemical was applied undiluted at a concentration of 0.1 ml in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test article. The right eye remained untreated and served as the reference control. The eyes of each animal were examined 1, 24, 48 and 72 hours, after administration. Body weight was measured at day 1 and at termination of the study. Rabbits were observed for mortality daily. Rabbits were killed by an intraveneous injection of T61 into the ear vein. The irritation was assessed according to the OECD Guidelines for testing of Chemicals, Section 4, number 405 "Acute Eye Irritation/Corrosion". Slight coloration was observed, no corrosive and toxic symptoms were observed in the test animals. Based on obove observations and a primary irritation score of 1.1, the test chemical can be classified as "Not irritant" to the rabbit eye according to the CLP regulation.