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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
skin 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 404 (Acute Dermal 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; untreadted sites served as controls. The powdered material was provided by the Toxicology Pharmacy in envelopes with 500 mg/envelope for the cutaneous irritation portion of the study. Since pure drug substance was used in this study, no analyses were required.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system 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

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated left side of the animal served as control for skin irritation study.
Amount / concentration applied:
500 mg of solid compound
Duration of treatment / exposure:
Approximately 4 hours
Observation period:
72 hours
Number of animals:
3 rabbits

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0

Any other information on results incl. tables

No clinical signs of toxicity were observed in any rabbit and no deaths occured during the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Dermal application of PCR 0665 did not produce any adverse reactions.
Based on the results of this study, PCR 0665 does not meet the R-rating criteria for skin irritation.