2-methoxy-N,N,β-trimethyl-10H-phenothiazine-10-propylamine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-methoxy-N,N,β-trimethyl-10H-phenothiazine-10-propylamine

EC Number:

212-706-8

EC Name:

2-methoxy-N,N,β-trimethyl-10H-phenothiazine-10-propylamine

Cas Number:

851-68-3

Molecular formula:

C19H24N2OS

IUPAC Name:

2-methoxy-N,N,β-trimethyl-10H-phenothiazine-10-propylamine

Test material form:

solid: crystalline

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: S&K-LAP Kft.; 2173 Kartal, Császár út 135, Hungary
- Age at study initiation: 11 weeks
- Weight at study initiation: 2602-2844 g
- Housing: individually in metal cages
- Diet (e.g. ad libitum): ad libitum, C.HYF rabbit mixed diet produced by Cargill Takarmány Zrt., Karcag, Hungary
- Water (e.g. ad libitum): tap water (for human consumption) from automatic self supplying water system
- Acclimation period: 5 days in first animal, 6 days in second animal and 7 days in third animal

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-3 °C
- Humidity (%): 30-70%
- Air changes (per hr): above 10 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12-12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the contralateral eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,1 g of the test item was used for the study in undiluted form, as a single dose

Duration of treatment / exposure:

The eyes of the test animals were not washed out 24 hour after test item application, because the testi tem had been removed from the eye of test animals by physiological mechanisms.

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
The eyes of the test animals were not washed out 24 hour after test item application

SCORING SYSTEM:
Draize (1959) and OECD 405 (24 April 2002)

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

animal: 1,2,3

Time point:

other: 1 h, 24 h

Score:

>= 0 - <= 2

Max. score:

2

Reversibility:

fully reversible within: 48 h

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal: 1,2,3

Time point:

other: 1 h

Score:

>= 1 - <= 2

Max. score:

2

Reversibility:

fully reversible within: 24 h

Irritant / corrosive response data:

Treated and control eyes were examined at 1, 24, 48 and 72 hours after the application.

One hour after treatment some hyperemic blood vessels (score 1) were observed and the swelling of the conjunctivae was different from normal (score 1) in all animals. Discharge with moistening of the lids and hairs just adjacent to lids (score 2) of the conjunctivae was recorded in animal No.: 4677 and the amount of discharge of the conjunctivae was different from normal (score 1) in two animals (No.: 4678, 4686).

24 hours after treatment some hyperemic blood vessels (score 1) were observed in all animals.

48 hours after treatment all animals became free symptoms.

72 hours after treatment all animals were free of symptoms.

72 hours after the treatment the study was finished.

During the study the control eyes of animals were symptom-free.

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

In conclusion, test item Racem Tisercin base applied to the rabbits' eye mucosa caused slight to moderate conjunctival irritant effect which was fully reversible within 48 hours.

According to the EC criteria for classification and labelling requirements for dangerous substances and preparations, the test item does not have to be classified and has no obligatory labelling requirement for eye irritation.

According to regulation (EC) No. 1272/2008, the test item has not been classified into any category.