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Toxicological information

Respiratory sensitisation

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Administrative data

Endpoint:
respiratory sensitisation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Significant methodological deficiencies

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
- criteria for exposition of guideline OECD 403 were applied
- general recommendations in ASTM E 981-84 and by Alarie ( AlarieY. Sensory irritation by airborne chemicals. in CRC Crit Rev Toxicol. 1973, vol 2, no.3, p.299-363) concerning measurement methods and technologies were followed
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Versuchstierzucht Winkelmann, Borchen, Kreis Paderborn, Germany
- Age at study initiation: 1 - 2 months
- Weight at study initiation: 230 g ± < 10 %
- Housing: 4 animals per cage (makrolon cage, type 4)
- Diet: conventional laboratory diet, ad libitum
- Water : tap water with drinking water quality, ad libitum
- Acclimation period: 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 50 %
- Air changes (per hr): 10/h
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Route of induction exposure:
intradermal
Route of challenge exposure:
inhalation
Vehicle:
other: acetone
Concentration:
- Induction: 3 times intradermal (day 0: cranial, day 2: thoracal, day 4: caudal), 200 µL (2 x 100 µL) of a 0.3 % (w/v) solution of cyanuric chloride in acetone (controls 200 µL acetone)
- Challenge: 2.6 mg/cbm cyanuric chloride vapour (without vehicle), 30 min
- group 1 a (induced with vehicle) and group 2 a (induced with cyanuric chloride) on day 22, and a second challenge with acetylcholine ( 3 times 15 min with 0.1% w/v, 0.3 % w/v and 1.0 %w/v respectively) directly after the cyanurchlorid exposure and a third challenge with acetylcholine ( 3 times 15 min with 0.1% w/v, 0.3 % w/v and 1.0 %w/v respectively) on day 23
- group 1 b (induced with vehicle) and group 2 b (induced with cyanuric chloride) on day 24, and a second challenge with acetylcholine ( 3 times 15 min with 0.1% w/v (=7.5 mg/cbm), 0.3 % w/v (= 22.5 mg/cbm) and 1.0 % w/v (=75 mg/cbm) respectively) directly after the cyanurchlorid exposure and a third challenge with acetylcholine ( 3 times 15 min with 0.1% w/v, 0.3 % w/v and 1.0 %w/v respectively) on day 25
No. of animals per dose:
8, divided in two subgroups each, as only 4 animals could be exposed simultaneously
Details on study design:

RANGE FINDING TESTS:
in a range finding test concentrations above 3 mg/cbm cyanuric chloride were found to induced marked irritation based effects on the respiration, so 2.6 mg/cbm was chosen as challenge concentration

MAIN STUDY
see Concentration for details


Results and discussion

Results:
- body weights: cyanuric chloride induced animals have a slightly reduced body weight.
- lung weights: no significant difference in the absolute and relative lung weights between test item induced and control animals.
- lung pathology: both groups showed signs of macroscopic differences from the historical data, very likely due to pneumonia in both groups.
- Influence on respiration also seen in control animals.
- no toxicological significant differences in the respiratory sensibility between the two groups were found. Possible differences probably were masked by the infections in the respiratory track of both groups. Detailed results can be found in tables 1a and 1b .

Applicant's summary and conclusion

Conclusions:
Under the conditions of this study indications for a potential as a respiratory sensitzer are apparent but no clear conclusion can be drawn from the presented results as all animals (except one) in both groups showed macroscopic changes in the lung very likely a result of infections of the lung.