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Diss Factsheets

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:
From 22 OCT 1979 to 25 OCT 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: comparable to guideline
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: FDA guideline (Federal Register 38, No. 187, 27.9.1973)
Deviations:
no
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Dichloro-5,12-dihydroquino[2,3-b]acridine-7,14-dione
EC Number:
254-100-6
EC Name:
Dichloro-5,12-dihydroquino[2,3-b]acridine-7,14-dione
Cas Number:
38720-66-0
Molecular formula:
C20H10Cl2N2O2
IUPAC Name:
1,8-dichloro-5,7,12,14-tetrahydro-5,12-diazapentacene-7,14-dione; 1,9-dichloro-5,7,12,14-tetrahydro-5,12-diazapentacene-7,14-dione; 2,9-dichloro-5,7,12,14-tetrahydro-5,12-diazapentacene-7,14-dione

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: in house breeding (Hoe:HIMK(SPFWiga))
- Weight at study initiation: 1.5 to 2 kg
- Housing: single caged
- Diet: standard diet ERKA 8300 (Futtermittelwerk Robert Koch oHG, Hamm/Westf., Germany), ad libitum
- Water: ad libitum

Test system

Vehicle:
other: polyethylene glycol 400
Controls:
not required
Amount / concentration applied:
100 mg
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg test substance pasted with 3 drops of PEG 400
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiological solution of sodium chloride
- Time after start of exposure: 24 h


SCORING SYSTEM: according to OECD TG 405


TOOL USED TO ASSESS SCORE: magnifier (at 48 and 72 h reading 1 drop of sodium-fluorescein (0.1%) added for scoring)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
, #2, #4
Time point:
other: 24-48-72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: 24-48-72 h
Score:
0.67
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: 24-48-72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
other: redness
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
, #2, #4, #5, #6
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
Neither corneal nor iridial effects were observed at any time point during the test.
Conjunctival redness was observed in 6/6 animals at one and seven hours after instillation of the test item (score (redness): 1 or 2). This effect was fully reversible in 5/6 animals by 72 hours after application. In one animal this score ameliorated from 1 to 0 at the 48 hour reading, but then increased again to 1 at the 72 hour reading. Thus it cannot be stated as fully reversible in all animals.
Chemosis was visible in 2/6 animals at the one hour reading and in 1/6 animals at the 7 and 24 hour reading. This effect was fully reversible by 48 hours after application.
Other effects:
There was discharge observed in 5/6 animals one hour after instillation of the test material as well as in 2/6 animals at the seven hour reading.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP regulation
Conclusions:
It is concluded that the test is not irritating to eyes under these test conditions and has not to be classified according to the classification criteria of Regulation (EC) No 1272/2008. No corneal or iridial effects were observed. Conjunctival redness was observed in 6/6 animals at one and seven hours after instillation of the test item (score (redness): 1 or 2) as well as in 5/6 animals at the 24 h reading. These effects were fully reversible by 72 hours after application in 5/6 animals. In one animal this score ameliorated from 1 to 0 at the 48 hour reading, but then increased again to 1 at the 72 hour reading. Thus it cannot be stated as fully reversible in this animal. Nevertheless we assume this observation as not relevant due to the fact that the score has been already diminished to 0. Additionally in all other treated animals the observed positive conjunctival reactions vanished until the 72 hour reading. Chemosis was visible in 2/6 animals at the one hour reading and still in 1/6 animals at the 7 hour and 24 hour reading. This effect was fully reversible by 48 hours after application. Test material contains relevant amounts of the submission substance. Therefore the test results are considered adequate to fulfil the endpoint requirements.
Executive summary:

Test material was subject to an acute eye irritation/corrosion test in 6 rabbits according to FDA guidelines (similar to OECD TG 405). No corneal or iridial effects were observed until the end of the observation period (72 h). Conjunctival redness was observed in 6/6 animals at one and seven hours after instillation of the test item (score (redness): 1 or 2) as well as in 5/6 animals at the 24 h reading. These effects were fully reversible by 72 hours after application in 5/6 animals. In one animal this score ameliorated from 1 to 0 at the 48 hour reading, but then increased again to 1 at the 72 hour reading. Chemosis was visible in 2/6 animals at the one hour reading and still in 1/6 animals at the 7 hour and 24 hour reading. This effect was fully reversible by 48 hours after application.

As it can be plausibly assumed that the minimal redness observed in 1/6 animals after 72 hours would have been reversible, if the observation time would have been longer and because the mean values of the observed eye responses were below the critical values for classification according to the criteria of Regulation (EC) No 1272/2008, the test material is judged not to be irritating to eyes and has not to be classified for eye irritation.