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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 April 2002 to 18 April 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was conducted in accordance with International Guidelines and in accordance with the principles of Good Laboratory Practise (GLP).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): NALCO 01WC026 / PSO
- Lot/batch No.:XC1M0642

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: 7 - 9 weeks old
- Weight at study initiation: 1.424 to 1.618 kg
- Housing: Animals were housed individually in labelled cages with perforated floors (Scanbur, Denmark, dimensions 56x44x37.5cm)
- Diet (e.g. ad libitum): Standard laboratory rabbit diet (Teklad Global Rabbit Diet, code 2030, Harlan, Blackthorn, England) approx 100g /day. In addition hay was provided twice a week.
- Water (e.g. ad libitum): Free access to tap water
- Acclimation period: at least 5 days

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

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The other eye of each animal remained untreated and served as the reference control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml of test substance
Duration of treatment / exposure:
A single application of the test substance. Each animal was treated by instillation of 0.1 ml of the test susbstance, in the conjunctival sac of one eye after gently pulling the lower lid away from the eyeball. The lids were then gently held together t for about one second to prevent loss of the test substance.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 males
Details on study design:
SCORING SYSTEM: See table 1 of attachment S7.3.2 Eye Irritation Results Tables 1 - 3.pdf

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: 2% fluorescein in water

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 & 72 hours
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 & 72 hours
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 & 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 & 72 hours
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 & 72 hours
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 & 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 & 72 hours
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 & 72 h ours
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 & 72 hours
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 & 72 hours
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 & 72 hours
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 & 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
Instillation of the test substance into one eye of each three animals resulted in irriation of the conjunctiva, which was seen as redness, chemosis and discharge. The irriation had completely resolved within 24 hours in all animals.
No iridial irritation or cornela opacity was observed, and treatment of the eyes with 25% fluorescein 24 hours after treatment revealed no corneal epithelial damage in any of the animals.
There was no evidence of ocular corrosion.

For individual; and mean eye irriattion scores see See table 2 & 3 of the attachment S7.3.2 Eye Irritation Results Tables 1 - 3.pdf
Other effects:
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred

Any other information on results incl. tables

No staining of (peri) ocular tissues by the test substance was observed

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is not classified as an eye irritant.
Executive summary:

The study was carried out based on the guidelines 92/69 EEC, B.5, "Acute Toxicity - Eye Irritation" and OECD Guideline no. 405

"Acute Toxicity - Eye Irritation/Corrosion"

Single samples of 0.1 ml of the test substance 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 was seen as redness, chemosis and discharge. The irritation had completely resolved within 24 hours in all animals.

Based on these results and according to the EC criteria for classification and labelling the test substance is not classified as an eye irritant.