Registration Dossier

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:
30 April 2010 - 09 May 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Performed under GLP
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2002
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
2008
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
Remarks:
Statement of Compliance

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Steam Activated Carbon (High Skeletal Density activated carbon
- Physical state: powder
- Analytical purity: confidential
- Lot/batch No.: confidential
- Stability under test conditions: Stable under storage conditions
- Storage condition of test material: In refrigerator (range of 5 ± 3 °C, light protected

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories B.V., Kreuzelweg 53, 5961 NM Horst / The Netherlands
- Age at study initiation: 16 - 18 weeks
- Weight at study initiation: 2420 – 2584 g
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls
- Diet: Pelleted standard Kliba Nafag 3418 rodent maintenance diet available ad libitum
- Water: Community tap water from Füllinsdorf ad libitum
- Acclimation period:5-6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: No data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g/animal
- Concentration (if solution): undiluted (100%)
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 24, 48, and 72 hours
Number of animals or in vitro replicates:
3 males
Details on study design:
SCORING SYSTEM: The eye reactions were assessed according to the numerical scoring system listed in the Commission Regulation (EC) No 440/2008, B.5, at approximately 1, 24, 48, 72 hours after administration. Scleral reddening and ocular discharge were also assessed.

TOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic-lamp (Roth AG, 4153 Reinach / Switzerland)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal # 1,2 and 3
Time point:
other: 24, 48 and 72 hours
Score:
ca. 0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal # 1, 2 and 3
Time point:
other: 24, 48 and 72 hours
Score:
ca. 0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Remarks:
animal # 1, 2 and 3
Time point:
other: 24, 48 and 72 hours
Score:
ca. 0.67
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal # 1
Time point:
other: 24, 48 and 72 hours
Score:
ca. 0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal # 2
Time point:
other: 24, 48 and 72 hours
Score:
ca. 0
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal # 3
Time point:
other: 24, 48 and 72 hours
Score:
ca. 0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
The instillation of Steam Activated Carbon into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, chemosis of the conjunctivae and ocular discharge. These effects were reversible and were no longer evident 72 hours after treatment, the end of the observation period for all animals. No abnormal findings were observed in the cornea or for the iris light reflex of any animals at any of the examinations. No corrosion was observed at any of the measuring intervals. No clinical signs were observed.
Other effects:
No intercurrent deaths occurred during the course of the study. The body weight of the animals was within the range commonly recorded for this strain and age. Black test item remnants were observed in the treated eyes of all animals at the 1-hour reading (in one animal) or from the 1-hour to the 48-hour reading (2 animals).

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item did not induce significant or irreversible damage to the rabbit eye. Based on these results and according to the EU criteria outlined in Annex I of 1272/2008/EC (CLP/EU-GHS), Steam Activated Carbon does not have to be classified and has no obligatory labelling requirement with respect to eye irritation in rabbits.
Executive summary:

The primary eye irritation potential of Steam Activated Carbon was investigated according to OECD test guideline no. 405. The test item was applied by instillation of 0.1 g into the left eye of each of 3 young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test item instillation. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity and iris light reflex were 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.67, 0.67 and 0.67 for reddening and 0.33, 0.00 and 0.33 for chemosis. The instillation of Steam Activated Carbon into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, chemosis of the conjunctivae and ocular discharge. These effects were reversible and were no longer evident 72 hours after treatment, the end of the observation period for all animals. No abnormal findings were observed in the cornea or for the iris light reflex of any animals at any of the examinations. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed and no clinical signs were observed. Thus, the test item did not induce significant or irreversible damage to the rabbit eye. Based on these results and according to the EU criteria outlined in Annex I of 1272/2008/EC (CLP/EU-GHS), Steam Activated Carbon does not have to be classified and has no obligatory labelling requirement with respect to eye irritation in rabbits.