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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:
1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Study was performed equivalent or similar to the OECD 405 guideline and in compliance with the GLP Regulations. Study was terminated eralier due to severity of the responses.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
purity, storage conditions not reported
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N,N',N'-tetramethyl-2,2'-oxybis(ethylamine)
EC Number:
221-220-5
EC Name:
N,N,N',N'-tetramethyl-2,2'-oxybis(ethylamine)
Cas Number:
3033-62-3
Molecular formula:
C8H20N2O
IUPAC Name:
{2-[2-(dimethylamino)ethoxy]ethyl}dimethylamine
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): 5601-51-1
- Physical state: clear liquid
- Analytical purity: responsibility of the Sponsor
- Lot/batch No.: J-249
- Stability under test conditions: no apparent change change in the physical state of the test article during administration
- Storage condition of test material: no data
- Other: pH=3.2

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Sgarlat's Rabbitry, Harvey's Lake, Pennsylvania
- Age at study initiation: no data
- Weight at study initiation: 2.223-2.689 kg
- Housing:individually in cages sized in accordance with the "Guide for the Care and Use of Laboratory Animals" of the Institute of Laboratory Resources, National Research Council
- Diet (e.g. ad libitum): Wayne Rabbit Ration, ad libitum
- Water (e.g. ad libitum): fresh tap water, fit for human consumption, ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C±3°C
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12h dark/12h light


IN-LIFE DATES: From: 1985-07-02 To:1985-07-09

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution):


VEHICLE not applicaple
Duration of treatment / exposure:
1 second
Observation period (in vivo):
7 days (due to severity of clinical observations , study was terminated earlier).
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no



SCORING SYSTEM: observation
- Draize, J.H., et al., J. Pharm, Exp. Ther.82:377-390 (1944)


TOOL USED TO ASSESS SCORE: 2% sodium fluorescein stain

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1-hr
Score:
75.7
Max. score:
110
Remarks on result:
other: Draize, severely irritating
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 24 and 48 hours
Score:
102.3
Max. score:
110
Remarks on result:
other: Draize, extremely irritating
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 72
Score:
105.4
Max. score:
110
Reversibility:
not reversible
Remarks:
within 72 hours
Remarks on result:
other: Draize, extremely irritating
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: The maximum mean total score was measured
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: The maximum mean total score was measured
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: The maximum mean total score was measured
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: The maximum mean total score was measured
Irritant / corrosive response data:
Necrosis of the skin surrounding the treated eyes was also observed during the course of the study. Positive ocular responses were observed at 1, 24, 48 and 72 hours.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Due to the severity of the reactions prior to the Day 7 reading, the study was terminated (Draize Score=105.4 , extremely irritating).