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Toxicological information

Repeated dose toxicity: inhalation

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Administrative data

Endpoint:
sub-chronic toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only secondary literature
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
review article or handbook
Title:
Final amended report on safety assessment on aminomethyl propanol and aminomethyl propanediol
Author:
Burnett et al.
Year:
2009
Bibliographic source:
Int. J. Toxicol. 28(65): 141S-161S

Materials and methods

Principles of method if other than guideline:
An inhalation toxicity study of a hair spray containing 0.135% of the test substance was performed using female Charles River rats. The rats were exposed for 4 hours a day, 5 days a week for 13 consecutive weeks to an aerosol containing 10 or 100 mg/m3 of 2 different hair spray formulations. The the body weight was recorded and hematological and clincial chemistry parameters were measured. The rats were necropsied, and tissues were subject to histopathological examination. The study was performed in 1975.
GLP compliance:
no
Remarks:
performed prior to GLP
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Aminomethyl propanediol, AMPD

Test animals

Species:
rat
Strain:
other: Chr/CD Charles River
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Diet: The animals had acces to feed ad libitum
- Water: The animals had acces to water ad libitum

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
not specified
Vehicle:
not specified
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Temperature, humidity, pressure in air chamber: The temperature, pressure, and humidity levels were closely monitored.

TEST ATMOSPHERE
- Samples taken from breathing zone: Yes. Aerosol concentrations in the inhalation chambers were monitored hourly and adjusted as necessary.
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
4 hours per day
Frequency of treatment:
5 days per week, for 13 weeks (32 exposure days)
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
10, 100 mg/m3
Basis:
other: nominal concentration; 0.135% test substance in formulation with 3% ethylene maleic anhydride copolymer, 50%
Remarks:
Doses / Concentrations:
100 mg/m3
Basis:
other: nominal concentration; 0.135% test substance in formulation without 3% ethylene maleic anhydride copolymer, 50%
No. of animals per sex per dose:
16
Control animals:
yes
Details on study design:
- Dose selection rationale: 2 hair spray formulations (particle size not available) containing 0.135% of the test substance were tested. Hair spray formulation 1 contained 3% ethylene maleic anhydride copolymer, 50%; while formulation 2 did not contain the ethylene maleic anhydride copolymer. In addition, a control group was used.

After 32 exposure days, 5 animals of each species from each group were killed. The remaining test animals were killed starting 3 days after the last day of exposure.

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: No data

DETAILED CLINICAL OBSERVATIONS: No

BODY WEIGHT: Yes

FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No

FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No

WATER CONSUMPTION: No

OPHTHALMOSCOPIC EXAMINATION: No

HAEMATOLOGY: Yes

CLINICAL CHEMISTRY: Yes

URINALYSIS: No

NEUROBEHAVIOURAL EXAMINATION: No
Sacrifice and pathology:
GROSS PATHOLOGY: Yes.

HISTOPATHOLOGY: Yes.

Results and discussion

Results of examinations

Details on results:
CLINICAL SIGNS AND MORTALITY
The mortality in the control, 10% formulation 1, 100% formulation 1 and 100% formulation 2 groups was 0/16, 1/16, 0/16 and 1/16. The mortality was probably not an adverse effect of the test substance, as there was no dose-response relationship. No clinical signs were reported.

BODY WEIGHT AND WEIGHT GAIN
There were no statistically significant changes in body weight in any of the groups.

HAEMATOLOGY
There were scattered incidences of statistically significant differences in various hematology parameters; according to the authors there were no dose- or exposure-dependent trends were noted. This conclusion could not be verified as the data was not included in the review.

CLINICAL CHEMISTRY
There were scattered incidences of statistically significant differences in various clinical chemistry parameters; according to the authors there were no dose- or exposure-dependent trends were noted. This conclusion could not be verified as the data was not included in the review.

ORGAN WEIGHT
There were no differences in organ weight between the control and treatment groups.

GROSS PATHOLOGY
There were no notable gross pathology findings.

HISTOPATHOLOGY: NON-NEOPLASTIC
There were no notable histopathology findings.

Effect levels

Key result
Dose descriptor:
NOAEC
Effect level:
100 mg/m³ air (nominal)
Based on:
other: formulation with 0.135% test substance
Sex:
male/female

Target system / organ toxicity

Key result
Critical effects observed:
not specified

Applicant's summary and conclusion