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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
14 Jan 2008 - 21 Jan 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

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

Test material

Constituent 1
Reference substance name:
Ashes (residues), coal
EC Number:
931-322-8
Cas Number:
68131-74-8
Molecular formula:
Not applicable (UVCB substance)
IUPAC Name:
Ashes (residues), coal

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Breeding farm BioTest, s r.o., Konárovice, 281 25 Czech Republic, RČH CZ 21760152
- Age at study initiation: 4-5 months
- Weight at study initiation: 3.0-3.5 kg
- Housing: individually in metallic cages
- Diet (e.g. ad libitum): Standard pelleted diet TM-MAK 1 for rabbits and guinea pigs (made by Bergman, Mill Kocanda, Jesenice u Prahy) ad libitum
- Water (e.g. ad libitum): drinking tap water ad libitum
- Acclimation period: 6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 14 Jan 2008 To: 21 Jan 2008

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 g
Duration of treatment / exposure:
24 h
Observation period (in vivo):
1, 24, 48 , 72 h
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: the treated eye was rinsed with water.
- Time after start of exposure: 24 h


SCORING SYSTEM: Draize scores


TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of 3 animals
Time point:
other: 1 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of 3 animals
Time point:
other: 1 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of 3 animals
Time point:
other: 1 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of 3 animals
Time point:
other: 1 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
Clinical examination of eye

Rabbit No. 1:
1 hour: Conjunctivae - some blood vessels hyperaemic (injected)
24 hours: No alterations
48 hours: No alterations
72 hours: No alterations

Rabbit No. 2:
1 hour: Conjunctivae - some blood vessels hyperaemic (injected), Chemosis - some swelling above normal
24 hours: No alterations
48 hours: No alterations
72 hours: No alterations

Rabbit No. 3
1 hour: Conjunctivae - some blood vessels hyperaemic (injected)
24 hours: No alterations
48 hours: No alterations
72 hours: No alterations
Other effects:
No signs of systemic intoxication were observed.

Applicant's summary and conclusion

Interpretation of results:
other: The test substance does not fulfil the requirements to be classified according to CLP (EU-GHS) criteria.
Conclusions:
The following changes were observed in the treated eyes at 1 h post-application: some blood vessels were hyperaemic (injected) in all animals, and in one animal, some swelling above normal was noted. At 24, 48 and 72 h after application no signs of eye irritation were observed. No clinical signs of systemic intoxication were detected. It was concluded that the test substance is not irritating to the eye of rabbits.