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EC number: 238-101-9 | CAS number: 14233-37-5
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:
- 04 OCTOBER 2018 to 16 MAY 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- OECD Guideline for testing of chemicals. Test Nº 405 (2017). Acute eye Irritation / corrosion
- Deviations:
- yes
- Remarks:
- Weren't performed all the clinical observations. his deviation was not considered to have any impact on the interpretation of the study results or to affect significantly either the integrity or the quality of the study.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,4-bis(isopropylamino)anthraquinone
- EC Number:
- 238-101-9
- EC Name:
- 1,4-bis(isopropylamino)anthraquinone
- Cas Number:
- 14233-37-5
- Molecular formula:
- C20H22N2O2
- IUPAC Name:
- 1,4-bis[(propan-2-yl)amino]-9,10-dihydroanthracene-9,10-dione
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Room temperature (ca.23ºC) and protected from light
- Age at study initiation: 10 weeks old
- Weight at study initiation:
- Housing: 1 animal per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3ºC
- Humidity (%): 30-70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12:12
IN-LIFE DATES: From: 04/10/2018 To: 05/11/2018
Test system
- Vehicle:
- other: 0.5% w/v methylcellulose
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required): SLBR8963
- Purity: 0.5% w/v methylcellulose - Duration of treatment / exposure:
- 24 h.
test item administration and on day 7, 14, 21 of the study - Observation period (in vivo):
- Both eyes were graded and recorded 24h prior to test item administration and approximately 1h, 24h, 48h and 72h after test item administration
- Number of animals or in vitro replicates:
- 1 animal to be used in the initial test and 2 animals to be used in the confirmatory test (if deemed necessary)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Saline solution B Braun (0.9% w/v NaCl)
- Time after start of exposure: 24h
SCORING SYSTEM:
Grading of ocular lesions – Draize eye test
TOOL USED TO ASSESS SCORE:
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: 0= No ulceration or opacity; 0= normal
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: 0= No ulceration or opacity; 0= normal
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: 0= No ulceration or opacity; 0= normal
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: 0= No ulceration or opacity; 0= normal
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: 0= No ulceration or opacity; 0= normal
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: 0= No ulceration or opacity; 0= normal
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: 0= No ulceration or opacity; 0= normal
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: 0= No ulceration or opacity 0= normal
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Over the initial test, ocular reactions recorded in animal ID1, approximately 1 hour after exposure to the test item and after 8h post dose clinical observations were recorded with no ocular reactions being observed.
Also in the test item treated eye no signs were observed on days 2, 3 and 4 after 24h, 48h and 72h post dose respectively.
Thereby, since the initial test did not reveal irritant or corrosive effects, the Confirmatory test was conducted
with two additional animals (Animal ID2 and ID3) in a simultaneous manner.
Animal ID2 and Animal ID3 were treated simultaneously and no ocular reactions were observed on the administration day and after 24h, 48h and 72h post dose
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the results obtained in this study and under the assayed experimental conditions, on the basis of the Regulation (EC) No 1272/2008 (On classification, labelling and packaging of substances and mixtures) and the OECD Guideline No. 263 (Guidance Document on an Integrated Approach on Testing and Assessment (IATA) for Serious Eye Damage and Eye Irritation) the test item 1,4-bis(isopropylamino)anthraquinone can be considered to not have irritant or corrosive effects on the eyes of female New Zealand White rabbits after a single dose administration.
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