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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993-08-24
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EPA OPP 81-6 (Skin Sensitisation)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was conducted in 1993 when the GPMT was an internationally accepted and recommendet method.

Test material

Constituent 1
Chemical structure
Reference substance name:
3-iodo-2-propynyl butylcarbamate
EC Number:
259-627-5
EC Name:
3-iodo-2-propynyl butylcarbamate
Cas Number:
55406-53-6
Molecular formula:
C8H12INO2
IUPAC Name:
3-iodoprop-2-yn-1-yl butylcarbamate
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: P 9303-7021

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 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:
TEST ANIMALS
- Source: Mollegaard Breeding Centre Ltd, Ejby, DK-4623 Lille Skensved
- Females nulliparous and non-pregnant: not specified
- Microbiological status of animals, when known: SPF
- Age at study initiation: adult
- Weight at study initiation: 233 - 306 g
- Housing: The guinea pigs were housed in opaque PPL (Type IV) cages, two or three to a cage
- Diet: ad libitum
- Water: ad libitum
- Indication of any skin lesions: none

ENVIRONMENTAL CONDITIONS
- Temperature: 21 +/- 3 °C
- Humidity: 55 +/- 15 %
- Air changes: 10 per hr
- Photoperiod: 6 a. m. to 6 p. m. light

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
paraffin oil
Concentration / amount:
0.08 % (w/w)
Day(s)/duration:
day 0
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
3.12 % (w/w)
Day(s)/duration:
day7 / 48 h
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
0.32 %
Day(s)/duration:
day 21 / 24 h
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Neg control: 10
Positive control: 10
Test item: 20
Details on study design:
RANGE FINDING TESTS:
- investigation of intradermal irritancy of the test article
- investigation of topical irritancy of the test article
- investigation of topical irritancy of the test article on the flank of the animals using closed patch tests as in the main study

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1 intradermal; 1 epicutaneous
- Exposure period: single injection and 48 h
- Test groups: 1
- Control group: negative control and positive control
- Site: dorsal skin and flank
- Frequency of applications: single applications
- Concentrations: 0.08 % (w/w) amd 3.12 % (w/w)

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 21
- Exposure period: 24 h
- Test groups: 1
- Control group: negative control and positive control
- Site: flank
- Concentrations: 0.32 %
- Evaluation (hr after challenge): 24, 48, 72
Positive control substance(s):
yes
Remarks:
Dinitrochlorbenzene (DNCB)

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
No positive skin responses were observed in 9 animals.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.1 %
No. with + reactions:
9
Total no. in group:
9
Clinical observations:
Positive skin reaction were seen in 9 out of 9 animals.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.32 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No positive skin reactions were observed in 20 animals.

Any other information on results incl. tables

Table 1 Results of Magnusson Kligman Maximisation method

 

time

application

Observations/Remarks

Induction 1

day 0

intradermal

irritation

Induction 2

day 7

topical

no skin reactions

Challenge

day 21

topical

 

Scoring 1

24 hours after challenge application

 

no skin reactions

Scoring 2

48 hours after challenge application

 

no skin reactions

Scoring 3

72 hours after challenge application

 

no skin reactions

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No positive skin reactions were seen following challenge with the test item. Hence, it is concluded that the test article did not produce a delayed contact hypersensitivity in guinea pigs.
Executive summary:

The allergenic potential of the test item was investigated according to one of the methods recommended in the OECD Guidelines No. 406, "Skin Sensitization", 1992. The delayed contact hypersensitivity test used was the Guinea Pig Maximization Test described by B. Magnusson and A.M. Kligman.

Forty animals divided into a positive control and a negative control group each with 10 animals and a test group with 20 animals were included in the study. The study comprised an induction and a sensitization (challenge) phase. The induction procedure consisted of intradermal injections and a closed patch topical application of the test article, positive control article (l-chlor-2,4-dinitorbenzol) or vehicle (paraffin oil and petrolatum) on the back of the guinea pigs, one week apart. The challenge procedure consisted of a closed patch topical treatment on the flank 3 weeks after the intradermal induction.The following concentrations were used for the induction and challenge phase.

 

Test article

Pos. control article

Intradermal induction

0.08 % (w/w)

0.1 % (w/w)

Dermal induction

3.12 % (w/w)

1.0 % (w/w)

Challenge exposure

0.32 % (w/w)

0.1 % (w/w)

 

The skin reactions were evaluated 24, 48 and 72 hours after the challenge application. No positive skin reactions were observed after challenge in the test group.

Hence, it is concluded that the test article did not produce a delayed contact hypersensitivity in guinea pigs.