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:
06-JUL-2006 to 25-JUL-2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

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:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
black sticky powder, Purity: Content of organic part (Na-salt): approx. 80 %; Oligomers: 13 %; Main component: approx. 53 %; Stability of test item: Stable under storage conditions; Storage: At room temperature, desiccated and light protected.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Test System: Young Adult New Zealand White Rabbit (SPF)
Number of animals per test: 3 (Animals of both sexes were used)
Age at treatment: 11-12 weeks (male); 13-14 weeks (females)
Identification: By unique cage number and corresponding ear number.
Acclimatization: Under laboratory conditions after health examination. Only healthy animals were used for the study.
Allocation: Male no. 7 and Female Nos: 8 – 9

Conditions
Standard Laboratory Conditions.
Air-conditioned with ranges for room temperature of 17 - 23 °C and relative humidity 30-70 % and approximately 10-15 air changes per hour. Room temperature and humidity were monitored continuously and values outside of these ranges may have occasionally occurred, usually following room cleaning. These transient variations were considered not to have any influence on the study and, therefore, these data were not reported but were retained at RCC. 12 hours artificial fluorescent light/12 hours dark, music during the light period.
Accommodation: Individually in stainless steel cages with feed hoppers, drinking water bowls. Wood blocks and haysticks 4642 were provided for gnawing.
Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet (batch 24/06) ad libitum.
Water: Community tap water, ad libitum.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the right eye remained untreated and was used as the control
Amount / concentration applied:
0.1 g per animal
Duration of treatment / exposure:
no data
Observation period (in vivo):
Viability/mortality: Daily from acclimatization of the animals to the termination of test.
Clinical signs: Daily from acclimatization of the animals to the termination of test.
Body weight : At start of acclimatization, on the day of application and at termination of observation.
The eyes of each animal were examined approximately 1, 24, 48 and 72 hours as well as 7, 14 and 21 days after test article application.
Number of animals or in vitro replicates:
3
Details on study design:
The eyes of the animals were examined one day prior to test item administration.
Animals with overt signs of ocular injury or irritation which may have interfered with the interpretation of the results were not used in the test.
On the day of treatment, 0.1 g of test item was placed in the conjuctivial sac of the left eye of each animal 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 test item. The right eye remained untreated and served as the reference control. The treated eyes were not rinsed after instillation. The eyes of each animal were examined approximately 1, 24, 48 and 72 hours as well as 7, 14 and 21 days after test article application.

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:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1.44
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
The instillation of test item into the eye resulted in mild to moderate, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and chemosis. These effects were reversible and were no longer evident 14 days after treatment, the end of the observation period for all animals. A slight black staining produced by the test item was visible in 2 animals 1 hour after application. The staining did not persist. No abnormal findings were observed in the cornea or iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals.
Other effects:
No clinical signs were observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item did not induce significant or damage to the rabbit eye.
Executive summary:

The primary eye irritation potential of test item was investigated according to OECD test guideline No.405. The test item was applied by instillation of 0.1g into the left eye of each of three young adult New Zealand White rabbits. Scoring of irration effects was performed approximately 1, 24, 48 and 72 hours as well as 7, 14 and 21 days after test article application for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 1.00, 1.67 and 1.67 for reddening, respectively and 0.00 in all three animals for chemosis.

The instillation of test item into the eye resulted in mild to moderate, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and chemosis. These effects were reversible and were no longer evident 14 days after treatment, the end of the observation period for all animals. A slight black staining produced by the test item was visible in 2 animals 1 hour after application. The staining did not persist. No abnormal findings were observed in the cornea or iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. No clinical signs were observed.

Based on the result of this test, it indicates that the test item shall not be classified in accordance with CLP (Regulation EC 1272/2008).