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Toxicological information

Repeated dose toxicity: inhalation

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Administrative data

Endpoint:
sub-chronic toxicity: inhalation
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Study period:
14 weeks in 2005
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Recent study conducted by NTP similarly to OECD guideline 413 with deviations: food consumption, hematology, ophthalmological examination, some organ weights were not recorded.

Data source

Reference
Reference Type:
other: data available on NTP website
Title:
Unnamed
Year:
2006

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day Study)
Deviations:
yes
Remarks:
(food consumption, hematology, ophthalmological examination, some organ weights were not recorded)
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Pin-2(3)-ene
EC Number:
201-291-9
EC Name:
Pin-2(3)-ene
Cas Number:
80-56-8
Molecular formula:
C10H16
IUPAC Name:
4,7,7-trimethylbicyclo[3.1.1]hept-3-ene
Constituent 2
Reference substance name:
4,6,6-trimethylbicyclo[3.1.1]hept-3-ene
IUPAC Name:
4,6,6-trimethylbicyclo[3.1.1]hept-3-ene
Details on test material:
- Purity ≥ 97%

Test animals

Species:
mouse
Strain:
B6C3F1
Sex:
male/female
Details on test animals or test system and environmental conditions:
After a 10- to 14-day quarantine period, animals are assigned at random to treatment groups.

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
not specified
Vehicle:
not specified
Remarks on MMAD:
MMAD / GSD: No data
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
14 weeks; 6 hours per day
Frequency of treatment:
Five times per week, weekdays only
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
25
Basis:
nominal conc.
Remarks:
Doses / Concentrations:
50 ppm
Basis:
nominal conc.
Remarks:
Doses / Concentrations:
100 ppm
Basis:
nominal conc.
Remarks:
Doses / Concentrations:
200 ppm
Basis:
nominal conc.
Remarks:
Doses / Concentrations:
400 ppm
Basis:
nominal conc.
No. of animals per sex per dose:
10
Control animals:
yes

Results and discussion

Effect levels

Dose descriptor:
NOAEL
Effect level:
50 ppm
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Presence of transitional cell hyperplasia of the urinary bladder.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The NOAEL in male and female rats is 50 ppm based on minimal to moderate hyperplasia observed in the transitional epithelium of the urinary bladder in animals treated at 100 to 400 ppm.
Executive summary:

In a 90-day inhalation study conducted by NTP similarly to OECD guideline 413, groups of 10 animals per dose and per sex were administered for 6 hours per day, 5 weekdays per week at 0, 25, 50, 100, 200 and 400 ppm for a total of 14 weeks. The animals were observed twice per day and weighed once per week. A complete histopathologic evaluation including treatment-related gross lesions was performed on all animals including early death animals. Treatment-related lesions (target organs) were identified and these organs and gross lesions were examined to a no-effect level.

Similar effects were observed in male and female mice from the same dose level (100 ppm): minimal to moderate hyperplasia observed in the transitional epithelium of the urinary bladder.

The NOAEL in male and female rats is 50 ppm based on minimal to moderate hyperplasia observed in the transitional epithelium of the urinary bladder in animals treated at 100 to 400 ppm.

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