Benzenemethanol, 3-hydroxy-.alpha.-[[methyl(phenylmethyl)amino]methyl]-, (.alpha.S)-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

3-[(1S)-2-[benzyl(methyl)amino]-1-hydroxyethyl]phenol

Cas Number:

286426-31-1

Molecular formula:

C17 H20 O2

IUPAC Name:

3-[(1S)-2-[benzyl(methyl)amino]-1-hydroxyethyl]phenol

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Physical state: solid
- Analytical purity: 99,7 %
- Storage condition of test material: room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-88353 Kißlegg
- Weight at study initiation: 3 kg, 3.6 kg, 2.8 kg
- Housing:Individually housed in ABS-plastic rabbit cages, floor 24 cm²
- Diet : Free access to Altromin 2123 maintenance diet rabbit, rich in crude fiber, totally-pathogen-free-TPF
- Water : Free access to tap water ( drinking water, municipalresidue control, microbiol. controlled periodically )
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 -21
- Humidity (%): 45-65
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12:12 ,light 6:30 - 18:30

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Observation period (in vivo):

96 h

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: 286,285,297

Time point:

other: 1,24,48,72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

animal: 286,285,297

Time point:

other: 1,24,48,72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: 286,285,297

Time point:

other: 1,24,48, 72 h

Score:

0 - 1

Max. score:

3

Reversibility:

fully reversible within: 96 h

Results 4

Irritation parameter:

chemosis score

Basis:

animal: 286,285,296

Time point:

other: 1,24,48,72 h

Score:

0 - 1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritant / corrosive response data:

see table 1/2/3

Any other information on results incl. tables

Tabel 1 Eye Irritation Scores

Animal No.	hour p.appl.		Cornea	Iris	Conjunctivae A	Conjunctivae B	Sub Totals	Cumul. Score
			T / C	T / C	T / C	T / C	Cn Ir Cj
286 female	1	nr	0 /0	0 /0	1/0	1/0	0 0 2	2
	24	nr	0 /0	0 /0	1/0	0 /0	0 0 1	1
	48	nr	0 /0	0 /0	1/0	0 /0	0 0 1	1
	72	nr	0 /0	0 /0	0 /0	0 /0	0 0 0	0
285 female	1	nr	0 /0	0 /0	1/0	1/0	0 0 2	2
	24	nr	0 /0	0 /0	1/0	0 /0	0 0 1	1
	48	nr	0 /0	0 /0	1/0	0 /0	0 0 1	1
	72	nr	0 /0	0 /0	0 /0	0 /0	0 0 0	0
596 female	1	nr	0 /0	0 /0	1/0	1/0	0 0 2	2
	24	nr	0 /0	0 /0	1/0	1/0	0 0 2	2
	48	nr	0 /0	0 /0	1/0	1/0	0 0 2	2
	72	nr	0 /0	0 /0	1/0	0 /0	0 0 1	1
	96	nr	0 /0	0 /0	0 /0	0 /0	0 0 0	0

T = Test , C = Control: A = Redness; B= Chemosis; nt = not rinsed;

marked figures = used for calculation

Table 2 Mean Cumul. Score - 24, 48 ,72 hour reading

Time	Cumul. Score	Mean Cumul. Score
24 h	4.00	1.33
48 h	4.00	1.33
72 h	1.00	0.33

Tabel 3 Individual and Total Mean Cumul. Score - 24 , 48, 72 hour reading

Animal	Sex	Cornra	Iris	Conjunctivae A	Conjunctivae B	Cumul. Score	Primary Irritation Score
286	f	0.00	0.00	0.67	0.00	0.67
285	f	0.00	0.00	0.67	0.00	0.67
296	f	0.00	0.00	1.00	0.67	1.67
Total Mean		0.00	0.00	0.78	0.22		1 .0

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Considering the reported data of this irritation study it can be stated that the test item caused minimal irritation but no corrosiv effects to the eye of
albino rabbits.
According to Directive 93/21 EEC the labelling of the test item as an eye irritant is not required.

Executive summary:

In this eye irritation study the test item L-Benzyladrianol Base was applied to the lower conjunctival sac of one eye of 3 NZW-rabbits ( Cr:KBL(NZW) BR) at a dose of 0.1 g per application site. The untreated other eye served as control.

Observation were calculated and compared to the control eyes, 1h , 24 h, 48 h, 72 h and 96 hours after application of the test item.

The eyes were not rinsed after 24 hours.

The application of the test item L-Benzyladrianol Base at a dose of 0.1 g caused minimal blepharospasm in all animals immediately after the application.

1 hour after application a slight erythema and chemosis of the conjunctivae was visible in all animals.

Minimal signs of irritation were visible until the 48 h reading in all of the 3 test animals and in one of the three animals at the 72 h

reading. No chnages were visible at the 96 h reading in any of the 3 test animals.

No corneal lesion were found upon fluorescein examination.

The test item produced no corrosion or irreversible effects in any of the animals.

The total mean cumulative scores of the 24, 48 and 72 hour reading did not exceed the limit values according to

Directive 93/21 EEC in any case.

No other toxic effects were observed.