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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:
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:
2019
Report Date:
2019

Materials and methods

Test guideline
Qualifier:
according to
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. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

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.