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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:
1993
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
1-bromo-3-chloropropane
EC Number:
203-697-1
EC Name:
1-bromo-3-chloropropane
Cas Number:
109-70-6
Molecular formula:
C3H6BrCl
IUPAC Name:
1-bromo-3-chloropropane
Details on test material:
Batch number : 9207093
Expiry : stable for at least three months
Purity : 99,6%
Appearence : colourless liquid
Storage conditions : room temperature in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Three healthy adult rabbits, in the weight range 2,4 to 3,3 kg, aged 10 to 14 weeks. The rabbits were selected without conscious bias for the study.
A standard laboratory diet SDS Stanrab (P) Rabbit Diet and drinking water were provided ad libitum.
Animal room temperature was maintained at approximately 19°C and relative humidity at 30-70 %. These environmental parameters were recorded daily. Air exchange was maintened at approximately 19 air changes per hour and lighting was controlled by means of a time switch to provide 12 hours of artificial light (07:00-19:00 hours) in each 24 hours period.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0,1 ml of the test substance
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
The eye of each animal was examinated prior to instillation of the test substance to ensure that there was no pre-existing corneal damage, iridial or conjunctival inflammation.
One animal was treated in advance of the others, to ensure that if a severe response was produced, no further naimals would be exposed (pilot animal).
A 0,1 ml amount of the test substance was placed into the lower everted lid of one eye of each animal.
The eyelids were then gently held together for one second before releasing. The contralateral eye remained untreated.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48 & 72 hours
Max. score:
4
Reversibility:
fully reversible within: 4 days
Remarks on result:
other: A corneal opacity was seen on animal #1
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48 & 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: Average beetween 24, 48 and 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48 & 72 hours
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: Average beetween 24, 48 and 72 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48 & 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 2 days
Remarks on result:
other: Average beetween 24, 48 and 72 hours
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48 & 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Average beetween 24, 48 and 72 hours
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48 & 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: Average beetween 24, 48 and 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48 & 72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 4 days
Remarks on result:
other: Average beetween 24, 48 and 72 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48 & 72 hours
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: Average beetween 24, 48 and 72 hours
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48 & 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Average beetween 24, 48 and 72 hours
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48 & 72 hours
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 2 days
Remarks on result:
other: Average beetween 24, 48 and 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48 & 72 hours
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Average beetween 24, 48 and 72 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48 & 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 4 days
Remarks on result:
other: Average beetween 24, 48 and 72 hours
Irritant / corrosive response data:
A corneal opacity was seen in one animal from 1 to 4 days after instillation and was accompanied by iridial inflammation (1 day after instillation only). Dulling of the cornea was seen in one further animal one hour after instillation only.
Diffuse crimson colouration of the conjunctivae was seen in all three animals and was accompanied in one animal by obvious swelling with partial eversion of the lids.
The eyes were normal seven days after instillation.
Other effects:
One animal vocalised for approximately 1 minute following instillation of the substance.
There were no other signs of toxicity or ill health in any rabbit during the observation period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Instillation of 1-bromo-3-chloropropane into the eye elicited temporary corneal opacification (one animal), transient dulling of the cornea (one animal), transient iridial inflammation (one animal) and slight to well-defined conjunctival irritation. All reactions had resolved seven days after instillation.
Since the 3 criteria of the table 3.3.2 of the regulation 1272/2008 are not fulfilled, 1-bromo-3-chloropropane does not require labelling concerning eye irritation in accordance with the CLP regulation.