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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:
1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented, according to accepted guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
reliability scoring based on 2002 guideline
Deviations:
yes
Remarks:
Six rabbits were tested in total and three of the test eyes were washed following administration
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
other: colourless, clear liquid
Details on test material:
- Name of test material (as cited in study report): Sec-butylchloride
- Physical state: liquid
- Lot/batch No.: Not reported
- Storage condition of test material: Stored in refrigerator
- Expiration date: Not specified by sponsor
- Stability under test conditions: not reported

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harald Schriever, Kaninchenfarm, D-2740 Bremervorde, Neuendamm 88
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: Individually
- Diet (e.g. ad libitum): ad libitum, Ssniff Mu Z (pellets), Ssniff Spezialdiaten GmbH
- Water (e.g. ad libitum): ad libitum, drinking water
- Acclimation period: At least 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 2°C
- Humidity (%): 50 to 85%
- Photoperiod (hrs dark / hrs light): 12/12


Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Undiluted
- Ph was 6.5

Duration of treatment / exposure:
0.1 mL of the test material was placed into the conjunctival sac of the left eye while the right eye served as control.
Observation period (in vivo):
1, 24, 48, and 72 hour after treatment
Number of animals or in vitro replicates:
3 animals in total
Details on study design:
SCORING SYSTEM:
Cornea opacity- degree of density (area most dense taken for reading): Grade

No ulceration or opacity: 0
Scattered or diffused areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible: 1
Easily discernible translucent areas, details of iris slightly obscured: 2
Nacreous areas, no details of iris visible, size of pupil barely discernible: 3
Opaque cornea, iris not discernible through the opacity: 4

Iris: Grade

Normal: 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, any of these or combination of any thereof, iris still reacting to light: 1
No reaction to light, haemorrhage, gross destruction (any or all of these): 2

Conjunctivae Redness (refers to the most severe reading of palpebral and bulbar conjunctivae, cornea, and iris): Grade

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

Chemosis (lids and/or nictating membranes): Grade

No swelling: 0
Any swelling above normal: 1
Obvious swelling with partial eversion of lids: 2
Swelling with lids about half-closed: 3
Swelling with lids more than half-closed: 4


TOOL USED TO ASSESS SCORE: Readings of ocular reactions were made 1, 24, 48, 72 hours after treatment using an ophthalmoscope.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 animals
Time point:
other: 1 hr
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 animals
Time point:
other: mean of 24, 48, 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 animals
Time point:
other: 1 hr
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 animals
Time point:
other: mean of 24, 48, 72 hrs
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
3 animals
Time point:
other: 1 hr
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 71 hours
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
3 animals
Time point:
other: mean of 24, 48, 72 hrs
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3 animals
Time point:
other: 1 hr
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 47 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3 animals
Time point:
other: mean of 24, 48, 72 hrs
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 24 hours

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under conditions of this test to investigate eye irritation/corrosion to rabbits 2-chlorobutane was found not to be classfied as irritant to eyes when applying the criteria for classification as described in CLP (Regulation (EC) No 1272/2008), respectively DSD (Directive 67/548/EEC).
Executive summary:

The substance showed a marked conjunctivae redness and chemosis directly after exposure to eyes of rabbits (1 hr following exposure), which quickly reversed after 48 hours. Thus, wehn applying the criteria as described in GHS respectively CLP (Regualtion (EC) No 1272/2008) the substance is not to be classified as having irreversible effects to eyes respectively being irritant to eyes.