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
Study period:
2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Guideline study performed under GLP. The reliability score assigned 'reliable with restrictions' relates to applicant expert assessment on the study documentation and test item fields as summarised.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

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
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Physical state: Liquid.- Storage condition of test material: Cool and dry- Other: yellowish- Stability under test conditions: at least 18 months.

Test animals / tissue source

Species:
rabbit
Strain:
other: SPF Albino ; Chbb:HM(SPF)
Details on test animals or tissues and environmental conditions:
TEST ANIMALS- Weight at study initiation: 1.9 - 2.0 kg- Housing: individual in PPO cages with perforated floor.- Diet (e.g. ad libitum): ad libitum Altromin 2123 (certificates of analysis retained)- Water (e.g. ad libitum): domestic drinking water; treated to prevent microbial growth (certificates of analysis retained)- Acclimation period: Housed pre-test for 7 days individually under same conditions as the main test.ENVIRONMENTAL CONDITIONS- Temperature (°C): 20 ± 3 °C- Humidity (%): 55 ± 15 %- Air changes (per hr): 10 per hour- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours lightIN-LIFE DATES: From: To: 04.04.2000 - 12.04.2000

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.1 mL- Concentration (if solution): neat (unchanged)
Duration of treatment / exposure:
24 hours treatment (rinsing performed at 24 hours with 20 ml 0.9% v/v Sodium Chloride solution post-reading and pre-corneal reading )
Observation period (in vivo):
4 days (observations were completed every day from day 1 to day 7 post treatment; terminated as all effects had reversed by day 7).
Number of animals or in vitro replicates:
4 (sex: female)
Details on study design:
REMOVAL OF TEST SUBSTANCE- Washing (if done): Yes.- Time after start of exposure: 24 hours.SCORING SYSTEM: Consistent to Draize scoring system.TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein (with supplemental UV-light to detect corneal damage).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
16
Remarks on result:
other: n = 4; maximum category score = 4; reading both before and after instillation of Fluorescein
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: day 7
Score:
0
Max. score:
16
Remarks on result:
other: n = 4; maximum category score = 4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
8
Remarks on result:
other: n =4; maximum category score = 2
Irritation parameter:
iris score
Basis:
mean
Time point:
other: day 7
Score:
0
Max. score:
8
Remarks on result:
other: n =4 ; maximum category score = 2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1.3
Max. score:
12
Remarks on result:
other: n =4 ; maximum category score = 3; conjunctivae redness -> maximum score = 2.0 at 24 hours.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: day 7
Score:
0
Max. score:
12
Remarks on result:
other: n =4 ; maximum category score = 3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
16
Remarks on result:
other: n =4 ; maximum category score = 4; chemosis -> maximum score = 2.0 at 24 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: day 7
Score:
0
Max. score:
16
Remarks on result:
other: n =4 ; maximum category score = 4; chemosis -> maximum score = 0
Irritant / corrosive response data:
Following scoring at 24, 48 and 72 h: No positive corneal scores. No positive iridal scores. Positive conjunctivae redness mean scores in 0/4 rabbits. Positive chemosis mean scores in 0/4 rabbits. All scores for all effect categories were less than or equal to 2.0 in all animals on all days (24 to 72hs; and up to 7 days). Discharge positive scores were also absent.

Any other information on results incl. tables

Individual scoring data was presented within the study report. No positive responses observed based on applicant recalculation of the results under the Regulation (EC) 1272/2008 criteria as amended.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, the test substance would not be considered as an eye irritant.
Executive summary:
The study was performed according to OECD TG 405 and EU Method B.5 acute eye irritation in vivo and in accordance with GLP. A volume of 0.1 ml of the test material was placed into the conjunctival sac of one eye of 4 animals sequentially using an initial sentinel organism. The other eye remained untreated and was used for control purposes. The eyes were examined and the changes were graded according to a numerical scale one hour, 24, 48 and 72 hours as well as 7 days after dosing. Well-defined signs of irritation were observed an the treated eyes. All effects were fully reversible within 7 days. The calculated mean values based on the results from the 24, 48 and 72 hour readings were calculated as: cornea: 0; iris lesion: 0; conjunctival redness: 1.33, 1.67, 1.33 and 1.00. Chemosis was 1.0 for all test organisms. 7 days after dosing all effects had fully reversed in all organisms. Under the conditions of this study the test substance has the potential to cause mild transient irritation based on applicant’s calculation of the mean scores following grading at 24, 48 and 72h and the individual scores, the test material is not considered to be irritating to the eye under Regulation (EC) 1272/2008 criteria.