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:
From the 25th of November to the 13th of December, 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted according to internationally accepted guideline.Justification for Read Across is detailed in the endpoint summary and it is further detailed in the report attached to the IUCLID section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Similar substance 01 of Acid Brown 191
IUPAC Name:
Similar substance 01 of Acid Brown 191
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Source: BRL, Biological Research Laboratories Ltd. Wolferstrasse 4, CH-4414 Fullinsdorf
Number of animals: 2 malel, 1 female
Age at start of treatment: male, 14 weeks, females 15 weeks
Body weight at start of or treatment: male 2.3-2.6 kg, females: 2.5 kg
Identification: by unique cage number and corresponding ear tags.
Acclimatization: four days under test conditions after veterinary examination.
Allocation: Animal Numbers, Male no 96-97 Female nos. 98

HUSBANDRY
Room No: 138
Standard Laboratory Conditions:Air-onditioned with 10-15 air changes per hour and hourly monitored environment with temperature 20±3 °C, relative humidity 40-70%, 12 hoursartificial fluorescent light/12 hours dark, music/light period.
Accommodation: individually in stainless steel cages equipped with an automatic cleaning and drinking system.
Diet: pelleted standard Kliba 341, Batch 52/90 rabbit maintenance diet (“Kliba”, Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum, Analysis for contaminants performed.
Water: community tap water from Itingen, ad libitumAnalysis for contaminants performed.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 g of the test article
Duration of treatment / exposure:
4 hours
Observation period (in vivo):
The eyes of each animal were examined 1, 24, 48 and 72 hours, 7 days and 14 days after administration. Viability, mortality: dailyClinical Symptoms dailyBody weight: day 1 of test (application day) and at termination of test on a Mettler PK 16 balanceThe eye reaction were wxamined at 1, 24, 48 and 72 hours, 7 and 14 days after administration.
Number of animals or in vitro replicates:
2 males, 1 female
Details on study design:
The eyes of the animals were observed one day prior to test article administration.0.1 g or the test article was placed in the conjunctival sac or the left eye of each animal after gently pulling the lower lid away from theeyeball. The lids were then gently held together ror about one second to prevent loss or the test article. The right eye remained untreated and served as the reference control.In cases of equivocal results when comparing the treated and untreated eyes, the illustrated guide rrom the Consumer Product Sarety Commission Washington, D.C. 20207 would be used for additional control purposes.Eye examinations were made with a slit—lamp 30 SL/M (C. Zeiss AG, Zuerich/Switzerland) and a Varta Cliptrix diagnostic—lamp (A. Riegger, Basel/Switzerland).The observation was terminated 14 days after administration of the test article.All rabbits were killed by an intravenous injection of T61 (Hoechst/AG) into the ear vein and discarded.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
43, 44, 45
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: not rinsed
Irritation parameter:
iris score
Basis:
animal: 45
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
43, 44
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
other: not rinsed
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
44 , 45
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: not rinsed
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal:
Remarks:
43
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: not rinsed
Irritation parameter:
chemosis score
Basis:
animal: 43
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: not rinsed
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
44, 45
Time point:
other: 14 days
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: not rinsed
Irritant / corrosive response data:
The substance showed a primary irritation score of 4.42 when applied to the rabbit eye mucosa.A brown to slight brown staining or the cornea, conjunctivae and eyelashes of the treated eyes by pigment or coloring of the test article was observed
Corneal opacity was observed in all animals. Two animals within 1 to 72 hours and one animal within 1 hour to 7 days.
Other effects:
No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.With the exception of animal no. 44 the body weight gain of the rabbits was similar. Due to minimal food consumption between days 6 and 15 of test animal.No necropsy was performed. All animals were killed and discarded.no. 44 lost weight. In addition to the laboratory diet (Kliba) hay was red starting with day.

Any other information on results incl. tables

Data arre summarized in tabular form, showing for each individual animal the irritation scores at the designated observation time, a description of the degree and nature of irritation, the presence or serious lesions and non—ocular effects.

To calculate the irritation effect all scores of each animal at each of the following reading times (24, 48, 72 hours) were used in calculating the respective mean values (Council Directive 83/467/EEC, July 1983 and 67/548/EEC, May 1987, Brussels, Belgium).

Applicant's summary and conclusion

Interpretation of results:
other: classified as an eye irritant according to the CLP Regulation 1272/2008
Remarks:
Classified according to the CLP Regulation
Conclusions:
Irritating for the rabbit eye
Executive summary:

Method

The eye irritation /corrosion property was tested on the substance according to the OECD Guideline 405 (Acute Eye Irritation / Corrosion) and the EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion), in GLP.

Observations

Under the conditions of this experiment, the substance was found to cause a primary irritation score of 4.42 when applied to the rabbit eye mucosa.

A brown to slight brown staining of the cornea, conjunctivae and eyelashes of the treated eyes by pigment or coloring of the test article was observed. Corneal opacity was observed in a and one animal within 1 hour to 7 days.

Results

According to EEC Council Directive, 83/467/EEC, July 1983 Brussels, Belgium, the mean value of the scores for each type of lesion, calculated rot each animal separately.

Due to the results the test article had to be classified as irritating to the eyes, also if no rinsing of the eye has been applied.