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Diss Factsheets

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:
9/28/92 - 9/30/92
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study followed FHSA Guidelines, CFR Title 16, Section 1500.42 (US Federal Hazardous Substances Act). Study was conducted according to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: FHSA Guidelines, CFR Title 16, Section 1500.42 (US Federal Hazardous Substances Act).
Principles of method if other than guideline:
A representative sample of test material (26.6 mg), equivalent to a volume of approximately 0.1 ml of CP-89,575 powder, was introduced into the conjunctival sac of the left eye; the right eye of each animal served as an untreated control. The treated eye of each rabbit was not rinsed after dosing. The animals were observed for clinical signs for 4 days and were weighed daily. On the day of dosing (day 1), the eyes were evaluated with minimal manipulation and without the use of fluorescein. Eyes were also evaluated 24, 48, and 72 hours after dosing.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
6-chloro-5-(2-chloroethyl)-1,3-dihydroindol-2-one
EC Number:
421-320-0
EC Name:
6-chloro-5-(2-chloroethyl)-1,3-dihydroindol-2-one
Cas Number:
118289-55-7
Molecular formula:
Hill formula: C10 H9 Cl2 N O CAS formula: C10 H9 Cl2 N O
IUPAC Name:
6-chloro-5-(2-chloroethyl)-2,3-dihydro-1H-indol-2-one
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
DESCRIPTION: A fine, orangish-brown powder with white flecks
MOLECULAR FORMULA: C1oH9Cl2NO
MOLECULAR WEIGHT: 230.09

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
SPECIES: Albino Rabbit (New Zealand White)
SOURCE: Millbrook Farm
SEX: 1 Male, 2 Females
WEIGHT RANGE: 2.86 to 3.02 kg


Test system

Vehicle:
not specified
Controls:
other: Untreated right eye was used as control
Amount / concentration applied:
26.2 MG
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
The animals were observed for clinical signs for 4 days and were weighed daily. On the day of dosing (day 1), the eyes were evaluated with minimal manipulation and without the use of fluorescein. Eyes were also evaluated 24, 48, and 72 hours after dosing
Number of animals or in vitro replicates:
3
Details on study design:
The animals were dosed on 10/14/92 and euthanized by intravenous sodium pentobarbital overdose on 10/17/92. The purity (activity) of the compound (95.6%) was not taken into consideration, and the stability of the test article under the conditions of the study was not determined.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Max. score:
1
Remarks on result:
other: Max. duration: 2 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Max. score:
0
Remarks on result:
other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 73 hrs
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Max. score:
0
Remarks on result:
other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Max. score:
0
Remarks on result:
other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
At 2 hours after dosing. a small amount of what appeared to be the test article, slight reddening (score= 1) of the palpebral conjunctivae, and slight chemosis (score= 1) were apparent in the treated eye of each animal. In addition, a small amount of discharge (score
= 1) was evident in the treated eye of Rabbit #2 and 3.

By 4 hours after dosing, slight circumcomeal reddening was apparent in each of the treated eyes, the degree of conjunctiva! reddening in Rabbit #3 had increased (score= 2), and the discharge in the eye of Rabbit #2 had subsided.


At 24 hours after dosing, the treated eye of two of the three rabbits(# 1 and 2) appeared essentially normal, while only slight reddening of the conjunctivae (score = 1) and slight
circumcorneal reddening were noted in the other animal. The integrity of the corneal epithelium was confirmed at 24 hours with the aid of fluorescein. When examined at 48 and 72 hours after dosing, each of the treated eyes appeared normal.


Other effects:
The untreated control eye of each animal was normal and unchanged throughout the test period.
All rabbits remained asymptomatic during the test period, and there was no effect on food consumption or body weight

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The results of this study indicate that CP-89,575 is not an ocular irritant in albino rabbits when tested according to FHSA guidelines (16 CFR 1500.42) because a positive reaction was not apparent in any of the treated eyes 24, 48, or 72 hours after the instillation of a single dose of 26.6 mg of the compound.