Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test procedure according to national (US) standards comparable to international guidelines. Study performed before implementation of GLP.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according 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:
(3-methacrylamidopropyl)trimethylammonium chloride
EC Number:
257-182-1
EC Name:
(3-methacrylamidopropyl)trimethylammonium chloride
Cas Number:
51410-72-1
Molecular formula:
C10 H21 N2 O. Cl
IUPAC Name:
trimethyl-[3-(2-methylprop-2-enoylamino)propyl]azanium chloride
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): N-Trimethylammoniumpropylmethacrylamidchlorid

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

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 g
- 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:
In all six treated animals, the cornea, iris as well as the conjunctiva were free of effects at all scorings.
Other effects:
no other effects observed

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, MAPTAC is not an eye irritant.
Executive summary:

In a primary eye irritation study according to US FHSA Federal regulation: 16 CFR 1500.42 (similar to OECD guideline 405), 0.1 g of MAPTAC ( according to supplier: purity ca. 50 ± 1%) was instilled into the conjunctival sac of the left eye 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. No irritating effects were observed.

In this study, MAPTAC is not irritant to the rabbit eye.

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.