Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13th to 14th August 1998
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study was conducted prior to approved LLNA method

Test material

Constituent 1
Chemical structure
Reference substance name:
6-(1-bromoethyl)-4-chloro-5-fluoropyrimidine
Cas Number:
188416-28-6
Molecular formula:
C6H5BrClFN2
IUPAC Name:
6-(1-bromoethyl)-4-chloro-5-fluoropyrimidine
Test material form:
liquid
Details on test material:
Amber Oil
Specific details on test material used for the study:
Identification: UK134,821
Appearance: Clear Yellow Liquid
Batch: 5494/96/1
Purity/Composition: 95.5%
Test item storage: At room temperature in the dark

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
The animals were approximately four to seven weeks of any on arrival and were acclimatised to the
experimental environment for five days prior to the start of the main study. The guinea-pigs were
within the weight range 332 -to 385g at the start of the study (Day 1). The guinea-pigs were housed ni groups of five in suspended nu.‘,tal cages with wire mesh floors in
Building R17 Room 14.
A vitamin C enriched guinea-pig diet (Harlan Teklad 9600 FD2 SQC) and drinking water were
provided ad hbittan. Hay was given thrice weekly.
The batch of diet used fbr the study was analysed for nutrients, possible contaminants or microorganisms,
likely to be present in the diet, and which, if in excess, may hase had an undesirable effect
on the test system. The certificates of analyses were lodged in Huntingdon Life Sciences Limited
Archives. There were no known contaminants present in the diet which were expected to be capable of
interfering with the study outcome.
Results of routine physical and chemical examination of drinking water, as conducted by the supplier
are made available to Huntingdon Life Sciences Ltd as quarterly summaries.
Animal room temperature was controlled within the range 16.5 to 30T and relative humidity within the
range 43 to 70%. These environmental parameters were recorded daily. Air exchange was maintained
at approximately 15 air changes per hour and lighting was controlled by means of a time switch to give
12 hours of artificial light (0700 - 1900 hours) in each 24 hours period.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: Alembicol D
Concentration / amount:
0.01% in Alembicol D
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
other: Alembicol D
Concentration / amount:
1%
Day(s)/duration:
48 hrs
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
No.:
#1
Route:
other: Topical
Vehicle:
other: Alembicol D
Concentration / amount:
0.1 and 0.05%
Day(s)/duration:
24 hrs
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
10
Positive control substance(s):
yes

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
other: Indermal Induction
Hours after challenge:
48
Group:
test chemical
Dose level:
0.01% in Alembicol D
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
Necrosis at sites receiving Freund's Adjuvant in test and control animals.Slight to well-defined irritation in test animals at sites receiving 0,01% v/v UK 134,821 and Alembicol D, slight irritation was observed in control animals receiving Alembicol D.
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
other: Induction Topical Induction
Hours after challenge:
48
Group:
test chemical
Dose level:
1% in Alembicol D
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
Slight erythema was observed in test animals following topical application with UK-134,821, 1% v/v Alembicol D, Slight erythema was seen in the control guinea-pigs.
Remarks on result:
positive indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
0.1% and 0.05% in Alembiol D
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation

Any other information on results incl. tables

There were no signs of ill health or toxicity throughout the study.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
UK-134,821 produced evidence of skin sensitization (delayed contact hypersensitivity) in all of the ten test animals.
Executive summary:

This study was performed to assess the skin sensitization potential of UK-134,821 usina the guinea-pig. The method followed was that described in: EEC Methods for the determination of toxicity. Annex to Directive 96/54/EEC (Official Journal No. L248., 30.9.96), Part B, Method B.6. Skin sensitiz,ation, OECD Guideline for Testing of Chemicals No. 406 Skin Sensitization". Adopted: 17 July 1992. MAGNUSSON, B. And KLIGMAN, A.M. (1970) Allergic Contact Dermatitis in the Guineapg: Identification ofeoniaet allergens, Thomas, C.C., Springfield, Illinois, U.S,A. The guinea pigs were dosed by intrademial injection and topical application as these are the routes of exposure required by the test guideline and method.

Based on the results of a preliminary study and in compliance with the guideline, the following dose levels were selected:

Intradermal injection: - 0.01% v/v in Alembicol D

Topical application: 1% v/v in Alernbicol D

Challenge application: 0.1 and 0.05% v/v in Membicol D

Ten test and five control guinea-pigs were used in this study. in this study UK-134,821 produced evidence of skin sensitization (delayed contact hypersensitivit).') in all of the ten test animals.