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Diss Factsheets

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:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods
Remarks:
Study performed before implementation of GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
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)
Qualifier:
equivalent or similar to guideline
Guideline:
other: US FHSA Federal regulation: 16 CFR 1500.42
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Remarks:
study performed before implementation of GLP

Test material

Constituent 1
Chemical structure
Reference substance name:
1-methyltrimethylene dimethacrylate
EC Number:
214-711-0
EC Name:
1-methyltrimethylene dimethacrylate
Cas Number:
1189-08-8
Molecular formula:
C12H18O4
IUPAC Name:
4-[(2-methylprop-2-enoyl)oxy]butan-2-yl 2-methylprop-2-enoate
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): 1,3-Butandioldimethacrylat

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): 18°C
- Humidity (%): 50 to 60%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light):12/12

IN-LIFE DATES: no data

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): as supplied
Duration of treatment / exposure:
eyes 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:
other: mean 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
other: mean 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
other: mean 24, 48, 72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
other: mean 24, 48, 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Transient conjunctival irritating effects were seen 1, 2 and 8 hours after application in all 6 animals (conjunctival redness grade 2 after 1 hour, grade 1 after 2 and 8 hours, slight chemosis grade 1 and discharge grade 2). All effects were completely reversible at the 24 h scoring. From 24 h onward all scores were zero.
Other effects:
no other effects reported

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In this study, 1,3-BDDMA is not an eye irritant (no need to be classified according to regulation (EC) 1272/2008 or UN-GHS).
Executive summary:

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

0.1 mL of 1,3-BDDMA (according to supplier's information: purity ca. 90%) 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 irritating effects were seen 1, 2 and 8 hours after application. All effects were completely reversible at the 24 h scoring. From 24 h onward all scores were zero.

In this study, 1,3-BDDMA is not an eye irritant.

NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.