Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study according to OECD guideline 405 (acute eye irritation/corrosion) study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-hexyloxyethanol
EC Number:
203-951-1
EC Name:
2-hexyloxyethanol
Cas Number:
112-25-4
Molecular formula:
C8H18O2
IUPAC Name:
2-(hexyloxy)ethanol
Constituent 2
Reference substance name:
Hexylglycol (EGHE)
IUPAC Name:
Hexylglycol (EGHE)
Details on test material:
- Name of test material (as cited in study report): n-Hexlglykol; Substance No. 83/145
- Expiration date of the lot/batch: 05/85

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Firma Gaukler, Offenbach/Main
- Weight at study initiation: mean value males: 2,62 kg; mean value females: 2.67 kg
- Housing: individual, stainless steel wire mesh cages
- Diet: Ovator Solikanin 4 mm, Muskator-Werke, Düsseldorf, ca. 130 g/day
- Water: tap water ca. 250 ml/day
- Acclimation period: at least 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 ml
- Concentration: undiluted
Duration of treatment / exposure:
unwashed (21 d)
Observation period (in vivo):
21 d
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM:
Criteria for assessment of ocular lesions:

Cornea*: opacity (op): Degree of density (area most dense taken for reading)
0 = No ulceration or opacity.
1 = Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible.
2 = Easily discernible translucent area, details of iris slightly obscured.
3 = Nacreous area, na details of iris visible, size of pupil barely discernible.
4 = Opaque cornea, iris not discernible through the opacity.

Area of cornea involved (ar):
1 ≥ 0 ; ≤ ¼
2 ≥ ¼ ; < ½
3 ≥ ½; < ¾
4 ≥ ¾

Conjunctivae*
redness (red): (Refers to palpebral and bulbar conjunctivae, cornea and iris)

0 = Blood vessels normal
1 = Some blood vessels definitely hyperaemic (injected)
2 = Diffuse, crimson colour, individual vessels not easily discernible.
3 = Diffuse beefy red.

Chemosis (sw): Lids and/or nictitating membranes the lids and hairs
just adjacent to
0 = No swelling.
1 = Any swelling above normal (includes nictitating membranes).
2 = Obvious swelling with partial eversion of lids
3 = Swelling with lids about half closed
4 = Swelling with lids more than half closed eye

Iris:*
0 = Normal
1 = Markedly deepened rugae, congestion, swelling, moderate circunicorneal hyperaemia, or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive).
2 = No reaction to light, haemorrhage, gross destruction (any or all of these).

Discharge (di):
0 = No discharge
1 = Any amount different from normal (does not include small amounts ob served in inner canthus of normal animals).
2 =Discharge with moistening of lids.
3 =Discharge with moistening of the lids and hairs, and considerable area around the eye

* Table according to the OECD guideline no. 405 (adopted February 24, 1987), EEC directive 92/69, L 383A, B. and EPA/OPPTS, 870.2400 (August 1998)

Calculation of primary irritation index:
Per animal and reading:
A = 5* (opacity)* (Area)
B = 5* (iris)
C = 2* (redness + swelling + discharge)

Individual irritation score (IIS):
IIS = A + B + C

Primary irritation score (PIS):
PIS = ∑(individual irritation scores of all treated animals after 24 h)+ ∑(individual irritation scores of all treated animals after 48h)+ ∑(individual irritation scores of all treated animals after 72 h) / N

with N= [3* (number of animals treated)]



Results and discussion

In vivo

Results
Irritation parameter:
other: primary irritation score
Basis:
mean
Max. score:
27
Reversibility:
not reversible
Irritant / corrosive response data:
details presented in the table below

Any other information on results incl. tables

Animal

1

2

3

Identification No

0377

0391

0397

Weight (kg)

2.62

2.72

2.62

Gender

male

female

female

Grading was done according to OECD guideline 405:

Readings

Animal

Cornea

Iris

Conjunctiva

Symptoms

Individual

irritation score

op

ar

red

sw

di

1h

1

0

0

1

2

2

2

PV

17

2

0

0

0

2

2

3

14

3

0

0

0

3

2

3

16

Mean

16

24h

1

1

4

1

2

1

1

PV

35

2

1

4

1

2

2

2

E/PV

37

3

0

0

1

3

2

2

17

Mean

30

48h

1

1

4

2

2

1

1

PV

38

2

1

4

1

2

1

2

E/PV

35

3

0

0

0

2

0

1

NA

6

Mean

26

72h

1

1

4

2

2

1

1

PV

38

2

1

4

1

2

0

2

E/PV

35

3

0

0

0

2

0

0

NA

4

Mean

26

8d

1

1

3

1

1

0

0

NA

22

2

2

3

0

1

0

0

CV/NA/HF

32

3

0

0

0

0

0

0

NA

0

Mean

18

21d

1

1

2

0

1

0

0

CV/NA

12

2

2

3

1

2

0

0

CV/NA

41

3

0

0

0

0

0

0

NA

0

Mean

18

Calculation: 245 / 9 = 27 (rounded in whole numbers)

Primary irritation score: 27

Abbriviations of symptoms:

CV: cornea vascularisation

E:   suppuration

HF: alopecia

NA: scar formation

PV: miosis

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: based on iris irritation at 72 h reading and non-reversibility after 21 days
Conclusions:
EU-classification: severely irritating (R41)
GHS-classification: serious eye damage category 1
Executive summary:

The study was accomplished according to OECD guideline 405 (acute eye irritation / corrosion).

An amount of 0.1 ml test substance was instilled into the right eye of 3 rabbits; the left eye served as control. Effects were recorded 1 h, 1 d, 2 d, 3 d, 8 d, 15 d & 21 d after instillation.

Conclusion: The test substance is highly irritating to the eyes (EU-classification: severely irritating (R41), GHS-classification: serious eye damage category 1).