Registration Dossier

Administrative data

Endpoint:
additional toxicological information
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards and is described in sufficient detail. The study was basically, but not fully in compliance with GLP principles, without affecting the validity and the overall results of the study.

Data source

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

Materials and methods

Type of study / information:
Study on respiratory irritation in mice after vapor inhalation
Principles of method if other than guideline:
Study according to a method of the American Society for Testing and Materials, Standard Test Method for Estimating Sensory Irritancy of Airborne Chemicals (ASTM E981). Groups of 4 male Swiss mice were exposed to 3.8, 7.7, 23 and 90 mg/m³ (0.46, 0.93, 2.79 and 10.9 ppm)Tridecylamine vapour for 45 minutes in a head-nose inhalation system. The post-exposure observation period was 7 days.
GLP compliance:
no
Remarks:
The experimental phases of this study were conducted under GLP conditions and the QAU inspected the study; however, the study report was not audited by QAU

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name: Tridecylamine (CAS No. 86089-17-0)
- Degree of purity >99%

Results and discussion

Any other information on results incl. tables

The respiratory rate depression increased with time at all but the lowest TS concentration. This effect increased with increasing test concentrations.

This effect is also reflected by the decrease of the calculated RD50-values with time:

.

RD50 (mg/m³)

LCL

UCL

RD50 (ppm)

early

526

no meaningful result

no meaningful result

63.7

middle

37.4

22.2

91.6

4.53

late

30.4

20.4

53.0

3.68

LCL = lower 95% confidence limit; UCL = upper 95% confidence limit

.

Reversal of the respiration rate was minimal during the recovery period.

Clinical signs were only seen in test group 3 (23 mg/m³; piloerection in 4 animals, reduced general state of one animal until days 6 and 7 of the observation period) and in test group 4 (90 mg/m³; piloerection in 4/4 animals, dragging respiration in 4/4 animals until day 1, reduced general state in 4/4 animals until days 1-2).

Body weights were decreased in the high dose test group from day 1 until day 7 post exposure, without reaching the p<0.05 level of statistical significance.

Pathology: on day 7 post exposure the absolute lung weights were decreased in the test groups 3 and 4 without reaching the p<0.05 level of statistical significance whereas the lung weights of the animals at 3.8 and 7.7 mg/m³ were comparable to controls. The relative lung weights were comparable in all animal groups.

Focal red discoloration in some lobes of the lung was found in 2/4 high dose animals. No abnormalities were detected in the other animals.

Applicant's summary and conclusion

Conclusions:
The test substance effects mainly pulmonary irritation in mice. The RD50 is steadily decreasing and is lowest with a value of about 30 mg/m³ ≈ 4 ppm during the last third of the exposure period.