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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 25 july 1995 to 31 July 1995
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Study according to OECD guideline but no data on GLP compliance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
4,5,6,7-tetrahydrothieno[3,2-c]pyridine hydrochloride
IUPAC Name:
4,5,6,7-tetrahydrothieno[3,2-c]pyridine hydrochloride
Constituent 2
Chemical structure
Reference substance name:
4,5,6,7-tetrahydrothieno[3,2-c]pyridinium chloride
EC Number:
249-220-0
EC Name:
4,5,6,7-tetrahydrothieno[3,2-c]pyridinium chloride
Cas Number:
28783-41-7
Molecular formula:
C7H9NS.ClH
IUPAC Name:
4,5,6,7-tetrahydrothieno[3,2-c]pyridin-5-ium chloride
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
The test article used in this study was PCR 0665 (4,5,6,7 Tetrahydrothieno-(3,2-c)Pyridine, Hydrochloride) batch 3SNL502. No control article was used; untreated sites served as controls. The powdered material was provided by the Toxicology Pharmacy in 100 mg/envelope for the ocular irritation portion. Since pure drug substance was used in this study, no analyses were required.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Three New Zealand White rabbits, one male and two females, five to six months old were obtained from Hazleton Research Products, Inc., identified by vendor- attached plastic ear tag or implanted microship and study animal identification number written with indelible ink pen inside the right ear, and housed one per cage. Prior to and during the study, the rabbits were caged in an environmentally controlled room maintained at approximately 64-68°F, 40-60% relative humidity, and 12 hour light/dark cycles. The rabbits were provided with approximately 125 grams/rabbit/day of Purina Cartified High Fiber Rabbit Chow No. 5325 lot 17 May 95 2A and 15 June 95 1B and municipal water (via an automatic watering system) ad libitum. The rabbits were weighed on Day-1 and weights ranged from 2.8 to 3.3 kg.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye of the animal served as control for eye irritation study.
Amount / concentration applied:
100 mg of pulverized solid compound
Observation period (in vivo):
72h
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Eye reactions were scored in accordance with the OECD Guidelines for Testing of Chemicals, Acute Eye Irriatation/Corrosion.
TOOL USED TO ASSESS SCORE: fluorescein. Sodium fluorescein (Fluor-I-Strips) was intilled into the eye, followed by irritation with 10 mL saline, at pretreatment and beginning at the 24 hr grading to determine the presence or absence of stainable corneal opacification and to evaluate the affected areas.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: conjunctival discharge
Basis:
animal #1
Time point:
other: 24 + 48 + 72h
Score:
2.3
Max. score:
3
Reversibility:
not fully reversible within: 72h
Irritation parameter:
other: Conjunctiva redness
Basis:
animal #1
Time point:
other: 24 + 48 + 72h
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
other: iris lesion
Basis:
animal #1
Time point:
other: 24 + 48 + 72h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24 + 48 + 72h
Score:
2.7
Max. score:
3
Reversibility:
not fully reversible within: 72h
Irritation parameter:
other: corneal opacity: degree
Basis:
animal #1
Time point:
other: 24 + 48 + 72h
Score:
0
Max. score:
0
Irritation parameter:
other: corneal opacity: surface
Basis:
animal #1
Time point:
other: 24 + 48 + 72h
Score:
0
Max. score:
0
Irritation parameter:
other: conjunctival discharge
Basis:
animal #2
Time point:
other: 24 + 48 + 72h
Score:
1.7
Max. score:
3
Reversibility:
not fully reversible within: 72h
Irritation parameter:
other: Conjunctiva redness
Basis:
animal #2
Time point:
other: 24 + 48 + 72h
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
other: iris lesion
Basis:
animal #2
Time point:
other: 24 + 48 + 72h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24 + 48 + 72h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 72h
Irritation parameter:
other: corneal opacity: degree
Basis:
animal #2
Time point:
other: 24 + 48 + 72h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 72h
Irritation parameter:
other: cornea opacity: surface
Basis:
animal #2
Time point:
other: 24 + 48 + 72h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 72h
Irritation parameter:
other: conjunctival discharge
Basis:
animal #3
Time point:
other: 24 + 48 + 72h
Score:
1.7
Max. score:
3
Reversibility:
not fully reversible within: 72h
Irritation parameter:
other: Conjunctiva redness
Basis:
animal #3
Time point:
other: 24 + 48 + 72h
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
other: iris lesion
Basis:
animal #3
Time point:
other: 24 + 48 + 72h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24 + 48 + 72h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72h
Irritation parameter:
other: corneal opacity: degree
Basis:
animal #3
Time point:
other: 24 + 48 + 72h
Score:
1
Max. score:
1
Reversibility:
not reversible
Irritation parameter:
other: corneal opacity: surface
Basis:
animal #3
Time point:
other: 24 + 48 +72h
Score:
1
Max. score:
1
Reversibility:
not reversible

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Only chemosis met the criteria of marked ocular lesion in a single rabbit. Therefore, no R-rating is required.
Based on the results of this study, PCR 0665 does not meet the R-rating criteria for eye irritation.