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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Sep - Nov 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2002
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
2004
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
1998
Qualifier:
according to guideline
Guideline:
other: JMAFF guidelines (2000); including the most recent partial revisions
Version / remarks:
2000
GLP compliance:
yes

Test material

Constituent 1
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST SYSTEM

Species: Albino rabbit, New Zealand White, (SPF-Quality). Recognized by international guidelines as the recommended test system (e.g. EC, OECD)
Source: Harlan, Horst, The Netherlands.

Number of animals: 3 Males.

Age and body weight: Animals used within the study were at least 6 weeks old and body weights were at least 1.0 kg.

Identification: Earmark.

Health inspection: A health inspection was performed prior to commencement of treatment, to ensure that the animals were in a good state of health. Special attention was paid to the eyes, which were free from any abnormality.

ANIMAL HUSBANDRY

Conditions: Animals were housed in a controlled environment, in which optimal conditions were considered to be approximately 15 air changes per hour, a temperature of 21.0 ± 3.0°C (actual range: 21.4 – 24.0°C), a relative humidity of 30-70% (actual range: 44 - 68%) and 12 hours artificial fluorescent light and 12 hours darkness per day.

Accommodation: Individually in labeled cages with perforated floors (Scanbur, Denmark, dimensions 56x44x37.5 cm). Acclimatization period was at least 5 days before start of treatment under laboratory conditions.

Diet: Pelleted diet for rabbits (K-H from SSNIFF® Spezialdiäten GmbH, Soest, Germany) approximately 100 grams per day. Hay (TecniLab-BMI BV, Someren, The Netherlands) was provided at least three times a week.

Water: Free access to tap water.

Results of analysis for each batch of diet (nutrients and contaminants), hay and water were assessed and did not reveal any findings that were considered to have affected the study integrity. All certificates and results of analysis are retained in the NOTOX archives.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: second eye served as the reference control
Amount / concentration applied:
Purity: According to substance idenity report
0.1 mL of undiluted test substance was applied
Duration of treatment / exposure:
24 hour(s)
Observation period (in vivo):
1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
3 males
Details on study design:
Study design: The study was performed in a stepwise manner and was started by treatment of a single rabbit (sentinel). The two other animals were treated in a similar manner one week later, after considering the degree of eye irritation observed in the first animal.

Treatment: Each animal was treated by instillation of 0.1 ml of the test substance in the conjunctival sac of one of the eyes 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 substance. The other eye remained untreated and served as the reference control.
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. Since no residual test substance was seen, the treated eyes were not rinsed with tepid tap water.
After the final observation, the animals were sacrificed by intra-venous injection of pentobarbital Euthesate® (Ceva Sante Animale BV, Naaldwijk, The Netherlands).

Observations:

Mortality/Viability: Twice daily.

Toxicity: At least once daily.

Body Weight: Day of treatment (prior to instillation) and at termination.

Irritation: The eyes of each animal were examined approximately 1, 24, 48 and 72 hours after instillation of the test substance. The irritation scores and a description of all other (local) effects were recorded.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 530 (Sentinel)
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable, no irritation
Remarks on result:
other: average
Irritation parameter:
cornea opacity score
Basis:
animal: 550
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable, no irritation
Remarks on result:
other: average
Irritation parameter:
cornea opacity score
Basis:
animal: 551
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable, no irritation
Remarks on result:
other: average
Irritation parameter:
iris score
Basis:
animal: 530 (Sentinel)
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable, no irritation
Remarks on result:
other: average
Irritation parameter:
iris score
Basis:
animal: 550
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable, no irritation
Remarks on result:
other: average
Irritation parameter:
iris score
Basis:
animal: 551
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable, no irritation
Remarks on result:
other: average
Irritation parameter:
conjunctivae score
Basis:
animal: 530 (Sentinel)
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: average; score 1 after 1 hour
Irritation parameter:
conjunctivae score
Basis:
animal: 550
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: average; score 1 after 1 hour
Irritation parameter:
conjunctivae score
Basis:
animal: 551
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: average; score 1 after 1 hour
Irritation parameter:
chemosis score
Basis:
animal: 530 (Sentinel)
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable, no irritation
Remarks on result:
other: average
Irritation parameter:
chemosis score
Basis:
animal: 550
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable, no irritation
Remarks on result:
other: average
Irritation parameter:
chemosis score
Basis:
animal: 551
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable, no irritation
Remarks on result:
other: average
Irritation parameter:
other: conjunctivae discharge
Basis:
animal: 530 (Sentinel)
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable, no discharge
Remarks on result:
other: average
Irritation parameter:
other: conjunctivae discharge
Basis:
animal: 550
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable, no discharge
Remarks on result:
other: average
Irritation parameter:
other: conjunctivae discharge
Basis:
animal: 551
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: average; score 1 after 1 hour
Irritant / corrosive response data:
Irritation:
Instillation of 0.1 mL of Sa03 into one eye of each of three rabbits resulted in irritation of
the conjunctivae, which consisted of redness and discharge. The irritation had completely resolved within 24 hours. 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.

Corrosion:

There was no evidence of ocular corrosion.
Other effects:
Colouration/Remnants: No staining of (peri) ocular tissues by the test substance was observed and no test substance remnants were seen.

Toxicity/Mortality: No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occured.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on these results Sa03 does not have to be classified and has no obligatory labelling requirement for eye irritation according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2004) and to the CLP Regulation (EC) 1272/2008.
Executive summary:

Acute eye irritation/corrosion study with Sa03 in the rabbit.

 

The study was carried out based on the guidelines described in:

OECD No.405 (2002) "Acute Eye Irritation / Corrosion"

EC, Council Directive 67/548/EEC, An. V,B.5, (2004) "Acute Toxicity: Eye Irritation / Corrosion"

EPA, OPPTS 870.2400 (1998): "Acute Eye Irritation"

JMAFF guidelines (2000); including the most recent partial revisions.

  

Single samples of 0.1 ml of Sa03 were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours after instillation.

  

Instillation of the test substance resulted in irritation of the conjunctivae, which consisted of redness and discharge. The irritation had completely resolved within 24 hours.

  

Based on these results Sa03 does not have to be classified and has no obligatory labelling requirement for eye irritation according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2004) and to the CLP Regulation (EC) 1272/2008.