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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:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test procedure according to national (US) standards comparable to international guidelines. Pre-GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Appraisal of the safety of chemicals in foods, druge and cosmetics, by the Staft of the Division of Pharmacology, US FDA, Bewertung von Augen-Läsionen nach Draize (1959)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
other: US FHSA Federal regulation: 16 CFR 1500.42
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Remarks:
study performed before implementation of GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Tetrahydrofurfurylmethacrylat

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.4 to 2.6 kg
- Housing: individually
- Diet (e.g. ad libitum): standard diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±1°C
- Humidity (%): 45 to 55%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light):12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated right eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted, as supplied
Duration of treatment / exposure:
eys were not rinsed after application
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): eyes were not rinsed for substance removal after treatment

SCORING SYSTEM: Draize scale

TOOL USED TO ASSESS SCORE: no data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 4 d
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 4 d
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3, #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: #4, #5
Time point:
24/48/72 h
Score:
0.67
Max. score:
7
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
Transient conjunctival redness grade 1 (some blood vessels hyperaemic (injected)) to 2 (diffuse, crimson colour; individual vessels not easily discernible) was seen up to 72 h after application in 5/6 animals. Chemosis grade 1 (some swelling above normal) was observed in 2/6 animals. All other animals showed no reactions. All effects were completely reversible within 4 days.
Other effects:
no other effects reported

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
Conclusions:
In this study, THFMA is not an eye irritant.
Executive summary:

In a primary eye irritation study similar to US FHSA Federal regulation: 16 CFR 1500.42 (similar to OECD guideline 405),

0.1 mL of THFMA (according to sponsor's information purity ca. 98%) was instilled into the conjunctival sac of the left eye of 6 New Zealand White rabbits without removing the test substance. Animals then were observed for 7 days. Irritation was scored by the method of Draize.

 

Transient conjunctival redness grade 1 (some blood vessels hyperaemic (injected)) to 2 (diffuse, crimson colour; individual vessels not easily discernible) was seen up to 72 h after application in 5/6 animals. Chemosis grade 1 (some swelling above normal) was observed in 2/6 animals. All other animals showed no reactions. All effects were completely reversible within 4 days. No irritating effects to the cornea and iris have been observed.

 

In this study, THFMA is not an eye irritant.

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