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Diss Factsheets

Administrative data

Description of key information

An eye irritation study was conducted on the test article. The result of the study was:

When tested according to OECD 405: Not irritating.

Key value for chemical safety assessment

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2012
Deviations:
no
Remarks:
No deviations occurred that negatively impacted the integrity of the study.
GLP compliance:
yes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3M Company, Lot LA-M000-2160-9
- Expiration date of the lot/batch: 05 April, 2022
- Purity test date: 16 January, 2015

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature (19-3-22.8 C)

FORM AS APPLIED IN THE TEST: Gas
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kitayama Labs
- Age at study initiation: 11 weeks old
- Weight at study initiation: 1924-2085 g
- Housing: Individually
- Diet (e.g. ad libitum): Pellet (RC4 Oriental Yeast Co.) ad libitum
- Water (e.g. ad libitum): Tap water ad libitum.
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.9-23.8
- Humidity (%): 45.5-75.1
- Air changes (per hr): 10-20
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 16 May, 2017 To: 27 May, 2017
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A single 1 second burst of the gaseous substance (0.7-0.8 g of the test article)

VEHICLE: None
Duration of treatment / exposure:
A single 1 second burst of the gaseous substance (0.7-0.8 g of the test article)
Observation period (in vivo):
72 hours
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): None

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
There were no observations of corneal opacity, iritis, or conjunctival redness or chemosis; mean (24, 48, and 72 hours) cornea, iris, conjunctival redness and chemosis scores for the three animals were 0. PII = 0/110.
Interpretation of results:
GHS criteria not met
Conclusions:
There were no observations of corneal opacity, iritis, or conjunctival redness or chemosis; mean (24, 48, and 72 hours) cornea, iris, conjunctival redness and chemosis scores for the three animals were 0. PII = 0/110. Not irritating per GHS.
Executive summary:

The eye irritation potential of MTDID 28136 was evaluated in New Zealand White Rabbits.  The study was conducted according to OECD 405 (2012) in compliance with OECD GLP.  MTDID 28136 (gas) was applied undiluted by single 1 second burst (0.7-0.8 g test material) to 3 male rabbits from a distance of 10cm directly into the right eye; left eye served as control. No severe eye impairment was observed at 1 hour after application. There were no observations of corneal opacity, iritis, or conjunctival redness or chemosis; mean (24, 48, and 72 hours) cornea, iris, conjunctival redness and chemosis scores for the three animals were 0. PII = 0/110. Not irritating per GHS.

Additional information

The eye irritation potential of MTDID 28136 was evaluated in New Zealand White Rabbits.  The study was conducted according to OECD 405 (2012) in compliance with OECD GLP.  MTDID 28136 (gas) was applied undiluted by single 1 second burst (0.7-0.8 g test material) to 3 male rabbits from a distance of 10cm directly into the right eye; left eye served as control. No severe eye impairment was observed at 1 hour after application. There were no observations of corneal opacity, iritis, or conjunctival redness or chemosis; mean (24, 48, and 72 hours) cornea, iris, conjunctival redness and chemosis scores for the three animals were 0. PII = 0/110. Not irritating per GHS.

Justification for classification or non-classification

Based on the results of the study, the test article is not classified for eye irritation according to GHS.