Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
Oct 13, 1998 to Nov 27,1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
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:
FAT40571/A
IUPAC Name:
FAT40571/A
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Description : Dark red / brown powder (solid)
Batch number : TVR50
Expiry date : September 1,2004
Purity composition : Ca. 65% / confidential information; available in sponsor's file.
Stability of test article : Stable at storage conditions.
Storage conditions : At room temperature (ca. 20 °C) away from direct sunlight.
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: TVR50
- Expiration date of the lot/batch: September 1,2004

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature (ca. 20 °C) away from direct
sunlight
- Stability under test conditions: Stable at storage conditions

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne
- Age at study initiation: 15 weeks
- Weight at study initiation: male : 3069 g ; females : 3308 - 3190 g
- Housing: Individually in stainless steel cages with an automatic cleaning system equipped with feed hoppers, drinking water bowls, with wood and haysticks for gnawing.
- Diet: Pelleted standard Provimi Kliba 3410 rabbit maintenance diet ad libitum (batch no. 62/98). Results of analysis are archived by RCC.
- Water: Community tap water from Itingen, ad libitum, in water bowls. Results of analysis are archived by RCC.
- Acclimation period: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±3
- Humidity (%): 40 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): fluorescent light on a 12 h light/dark cycle

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 g per animal
Duration of treatment / exposure:
The test article (undiluted) was placed in the conjunctival 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 article.
Observation period (in vivo):
Viability/mortality : Daily.
Clinical signs : Daily during the observation period.
Body weights : At start of acclimatization, on the first day of application and at termination of observation.
Scoring of irritation : performed approximately 1, 24, 48 and 72 h as well as 7, 14 and 21 days after test article application. The scores of each animal at the following reading times (24, 48 and 72 h) were used in calculating the respective mean values for each type of lesion.
Number of animals or in vitro replicates:
3 (1 male, 2 females)
Details on study design:
The eyes of the animals were examined one day prior to test article 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, the test article (undiluted) was placed in the conjunctival 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 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 from the Consumer Product Safety Commission, Washington, D.C. 20207 was used for additional control purposes (Washington, 1977).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 animal
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 animal
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
probability of weak irritation
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
probability of weak irritation
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3 animal
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Effects on redness of eyes were reversible within 14 days but difficulties were seen during the first three days to score the eyes due to the staining caused by the substance.
No corrosion of the cornea was observed at any of the reading times.
Other effects:
COLORATION: Reversible orange staining of the cornea, iris, conjunctivae (including nictitating membrane) and lid hairs by the test article was observed.
Scleral and conjunctival (nictitating membrane) staining was not reversible in all animals after 21 days.

Any other information on results incl. tables

No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.

 

IRRITATION

Application of the test article to healthy rabbit conjunctivae resulted in a primary irritation score of 0.33. Slight swelling of the conjunctivae including nictitating membrane and slight watery discharge was observed in all animals one hour after treatment. Slight conjunctival reddening was noted until day 7 of the observation period.

 

COLORATION

Orange staining of the cornea, iris, conjunctivae (including nictitating membrane), lid hairs and sclera by the test article was observed. Scleral and conjunctival (nictitating membrane) staining was not reversible in all animals after 21 days.

 

BODY WEIGHTS

The body weight of all rabbits were considered to be within the normal range of variability.

 

Individual eye scores

Animal

Number

Time point

Cornea

Iris

Conjunctiva

Redness

Chemosis

22

24 h

0

0

*

0

23

0

0

*

0

24

0

0

*

0

22

48 h

0

0

1

0

23

0

0

*

0

24

0

0

*

0

22

72 h

0

0

1

0

23

0

0

1

0

24

0

0

*

0

 

*      : Reaction and/or staining hampering evaluation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is classified as not irritating to eyes. As the irreversible staining does not impair sight, it is not relevant for classification and labeling according to the CLP guideline
Executive summary:

The primary irritation potential of FAT 40'571/A was investigated in New Zealand White rabbits according to OECD 405 and B.5 guideline by instillation of 0.1 g into one eye of each of three young adult New Zealand White rabbits. The treated eyes were not rinsed after application. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 h as well as 7, 14 and 21 days after test article application. The scores of each animal at the following reading times (24, 48 and 72 h) were used in calculating the respective mean values for each type of lesion.

Eye irritation scores found in animal number 22 after 48 h, animal 23 after 72 h and 7 days. These effects were subsided after 14 days. The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 h and then dividing the resulting total by the number of data points. The primary irritation score was 0.33 (max. 13). Swelling of the conjunctivae including nictitating membrane and watery discharge was observed in all animals one hour after treatment. Slight conjunctival reddening was noted until day 7 of the observation period. Orange staining of the cornea, iris, conjunctivae (including nictitating membrane), lid hairs and sclera of the treated eyes by the test article was observed. Scleral and conjunctival (nictitating membrane) staining was not reversible after 21 days, all other effects were reversed by Day 7. No corrosion was observed at any of the measuring intervals.