Butyl isocyanate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Documentation limited, no range finding for the induction, no information on control animals, several deviations from current guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Principles of method if other than guideline:

according Magnusson and Kligman; Number of animals: 15 test guinea pigs; no data on control guinea pigs; 
removal of hair is by shaving Induction: Intradermal Injections In an area of 30 cm² 10 injections (0.05 ml 
of a mixture of 0.5 ml test substance and 10 ml Freunds Complete Adjuvans) were placed during 2 weeks. 
After the last injection the animals were without treatment for 14 days (no further information available).
Challenge: Topical Application The animals were treated with 0,5 ml of a 0.1% solution which was applied 
on a patch under occlusive condition (no further information available)

GLP compliance:

no

Type of study:

guinea pig maximisation test

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

IUCLID4 Test substance: other TS: n-butyl isocyanate, no data on purity

In vivo test system

Test animals

Species:

guinea pig

Strain:

other: Pirbright-Hartley

Sex:

male

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal

Vehicle:

other: no data for the main study available

Induction 2

Concentration / amount:

induction: 0.05 ml of a mixture of 0.5 ml test substance and 10 ml Freunds adjuvant
challenge: 0.5 ml of a 0.1% solution

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

other: no data for the main study available

Challenge 2

Concentration / amount:

induction: 0.05 ml of a mixture of 0.5 ml test substance and 10 ml Freunds adjuvant
challenge: 0.5 ml of a 0.1% solution

No. of animals per dose:

15

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

0.5

Group:

test chemical

Dose level:

0.5 ml

No. with + reactions:

15

Total no. in group:

15

Clinical observations:

 30 minutes after application the site of injection were strongly reddened with blue red discoloration after 5-6 hours.

Remarks on result:

other: see Remark

Remarks:

Reading: 1st reading. . Hours after challenge: 0.5. Group: test group. Dose level: 0.5 ml. No with. + reactions: 15.0. Total no. in groups: 15.0. Clinical observations:  30 minutes after application the site of injection were strongly reddened with blue red discoloration after 5-6 hours..

Any other information on results incl. tables

REMARK:

Induction:
Immediately after the injection the animals had severe
itching. 30 minutes after application the site of injection
were strongly reddened with blue red discoloration after
5-6 hours. During the treatment-period of 14 days a distinct
exacerbation was observed. During the resting period partly
healing of the wounds with eschar formation occurred
Challenge: 
0.1%: 15/15 (no data on control animals available) with
distinct, up to strong erythema on the treated flanks with
slight edema in several animals. Some animals showed
itching. After 48 hours the treated skin of all animals was
slightly reddened; after 72 hours all effects were
reversible to a large extent (no further information
available)

RESULT:

Number of animals: 15 test guinea pigs; no data on control
guinea pigs; removal of hair is by shaving

Induction: Intradermal Injections

In an area of 30 cm² 10 injections (0.05 ml of a mixture of
0.5 ml test substance and 10 ml Freunds Complete Adjuvans)
were placed during 2 weeks. After the last injection the
animals were without treatment for 14 days (no further
information available).

Challenge: Topical Application

The animals were treated with 0,5 ml of a 0.1% solution
which was applied on a patch under occlusive condition (no
further information available)

Applicant's summary and conclusion

Interpretation of results:

sensitising

Remarks:

Migrated information

Executive summary:

according Magnusson and Kligman; Number of animals: 15 test guinea pigs; no data on control guinea pigs; 

removal of hair is by shaving Induction: Intradermal Injections In an area of 30 cm² 10 injections (0.05 ml 

of a mixture of 0.5 ml test substance and 10 ml Freunds Complete Adjuvans) were placed during 2 weeks. 

After the last injection the animals were without treatment for 14 days (no further information available).

Challenge: Topical Application The animals were treated with 0,5 ml of a 0.1% solution which was applied 

on a patch under occlusive condition (no further information available)

RESULT: substance is sensitising