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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

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:
other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Potassium trifluorozincate
EC Number:
237-537-7
EC Name:
Potassium trifluorozincate
Cas Number:
13827-02-6
Molecular formula:
F3Zn.K
IUPAC Name:
potassium trifluorozincuide
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Nocoloc Zn Flux
- Physical state: white powder
- Batch: 280200
- Analytical purity: > 99%
- Storage condition of test material: at room temperature in the dark
- Expiry date: 27 march 2003 (allocated by NOTOX, 1 year after receipt of the test substance)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan, Horst, The Netherlands
- Age at study initiation: At least 6 weeks
- Weight at study initiation: at least 1.0 kg
- Housing: Individually in labelled cages with perforated floors (Scanbur, Denmark, dimensions 56x44x37,5 cm)
- Diet: Standard laboratory rabbit diet (Teklad Global Rabbit Diet, code 2030, Harlan, Blackthorn, England) approx. 100 g per day. In addition, hay (BMI, Helmond, the Netherlands) was provided twice a week.
- Water: Tap water, ad libitum
- Acclimation period: At least 5 days before start of treatment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): of 21 ± 3
- Humidity (%): 30-70%
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
96.6 (95.8-97.8) mg
Duration of treatment / exposure:
24 hour
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3
Details on study design:
The eye irritation study was started by treatment of a single rabbit. The two other animals were treated in a similar manner 27 days later, after considering the degree of eye irritation observed in the first animal. Each animals was treated by instillation 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 in water (adjusted to pH 7.0) was instilled in both eyes of each animal to quantitatively determine corneal epithelial damage. When considered necessary, this procedure was repeated to assess recovery. Any bright green stained area, indicating epithelial damage, was estimated as a percentage of the total corneal area. Immediately after fluorescein examination on day 2, the treated eye was rinsed with approx. 50 mL tepid tap-water, using a velocity of flow which did not affect the eye, to remove residual test substance. For reference control, the other eye was also rinsed.
Observations: Mortality: 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 approx. 1, 24, 48 and 72 hours and 7, 14 and 21 days after instillation of the test substance.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 hr
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1-7 days
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 14-21 days
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 hr and 72 hr
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-48 hr
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 7-21 days
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 hr
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-72 hr
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 7 days
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 14 days
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 21 days
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 hr
Score:
3.33
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 hr
Score:
2.67
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48 hr
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72 hr
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 7 days
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 14-21 days
Score:
0
Max. score:
4
Irritant / corrosive response data:
- Opacity was seen in all animals and also as slight dulling of the normal lustre in one animal. As a result of the corneal injury, pannus (neovascularisation of the cornea) was apparent in two animals 7 days after instillation. The corneal injury and/or pannus had resolved in one animal within 72 hours and in two animals within 14 days. Irridial irritation (grade 1) was observed in two animals and had resolved within 72 hours and 7 days respectively. Reddness, chemosis, and discharche was completely resolved in one animal within 14 days and in the other within 21 days. Reduced elasticity of the eyelids was seen in one animal 72 hours after instillation and resolved within 14 days. Reduced elasticity of the eyelids was seen in one animal 72 hours after instillation and resolved within 14 days.
- There was no evidence of ocular corrosion
Other effects:
- No staining of (perl) ocular tissues by the test substance was observed. White blurring of the eyelids was present in all animals within 24 hours, which made observations of some parts of the eye difficult. The blurring resolved in all animals within 72 hours.
- No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurd

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is irritating to the eye.
Executive summary:

In a GLP-compliant OECD guideline 405 study, rabbits were exposed to Nocoloc Zn Flux to determine eye irritating properties. 97 mg of Nocoloc Zn Flux were instilled into the eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours and 7, 14 and 21 days after instillation. No staining and no systemic toxicity was observed. Opacity was seen in all animals and also as slight dulling of the normal lustrein in one animal. As a result of the corneal injury, pannus (neovascularisation of the cornea) was apperent in two animals 7 days after instillation. The corneal injury and/or pannus had resolved in one animal within 72 hours and in two animals within 14 days. Irridial irritation (grade 1) was observed in two animals and had resolved within 72 hours and 7 days respectively. Redness, chemosis, and discharche was completely resolved in one animal within 14 days and in the other two within 21 days. Reduced elasticity of the eyelids was seen in one animal 72 hours after instillation and resolved within 14 days. Based on the results the test substance was considered to be irritating to the eyes.