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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was carried out in compliance with GLP and US-EPA Vol 50 (§798.1150) Guideline, which is equivalent to OECD Guideline No. 403.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: US-EPA Vol 50 (§798.1150)
GLP compliance:
yes
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Hydrogen peroxide, 50% w/w

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc. Raleigh, North Carolina
- Age at study initiation: 8-9 weeks;
- Weight at study initiation: males: 262 - 277 g; females 217 – 257 g
- Fasting period before study:
- Housing: Doubly in suspended, stainless steel, wire mash cages during acclimation and non-exposure period; individually in 100 litre Plexiglass exposure chambers during exposure
- Diet (e.g. ad libitum): Purina Rodent Laboratory Chow Brand Animal Diet #5001 ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: All animals were acclimated for 11 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25 °C; 25 °C (during exposure)
- Humidity (%): 17-60 % (40-44 % during exposure)
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
whole body
Vehicle:
other: no data
Details on inhalation exposure:
The atmosphere was generated by bubbling air flow through a reservoir containing 1000 ml of 50% hydrogen peroxide. Particle size distribution measurements showed a particulate level of 0.020 mg/m3, which was comparable to background air levels thus indicating no appreciable aerosol formation.
Analytical verification of test atmosphere concentrations:
yes
Remarks:
Samples for colorimetric determination of vapours of hydrogen peroxide (50 %) were withdrawn once per hour
Duration of exposure:
4 h
Concentrations:
Nominal concentration: 7.7 [mg/L]
Analytical concentration: 0.17 [mg/L] (maximum attainable vapour)
No. of animals per sex per dose:
5 rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology
Statistics:
no data

Results and discussion

Preliminary study:
none
Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 170 mg/m³ air
Exp. duration:
4 h
Mortality:
No deaths occurred.
Clinical signs:
Observations noted during exposure included decreased activity and eye closure. Signs exhibited by animals upon removal from the chamber and during the two-hour post-exposure observation period on Day 1 included nasal discharge, excessive salivation and anogenital staining. During Test Week 1, test animals exhibited a few continuing responses such as dried red nasal discharge and dried red material on fur. During Test Week 2, animals exhibited some but not complete recovery from these signs.
Body weight:
Body weight at day 2 was slightly less than pre-test value. Recovery of weight occurred thereafter and all animals were in excess of their pre-exposure body weight by termination of the study.
Gross pathology:
No effects considered treatment-related were found. Lung weights were comparable to historical values
Other findings:
no other findings

Any other information on results incl. tables

none

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Classification according to Directive 2001/59/EC (adaptation of 67/548/EEC) is not necessary since at the maximum technical attainable vapour concentration of 0.17 mg/L no deaths occurred.
Executive summary:

The acute inhalation toxicity of hydrogen peroxide (50 %) aerosols was tested in male and female Sprague-Dawley rats according to US EPA Guideline Vol 50 (§798.1150). Animals received a single 4 -hour whole-body exposure to the maximum attainable aerosol concentration of 170 mg/m3. All tested animals survived the exposure and subsequent 14 -day post-exposure observation period. Signs of treatment were minimal during the exposure but a few responses such as nasal discharge were noted during the whole 14 -day observation period. A minimal, transient adverse effect upon body weight was produced by treatment. Otherwise, body weight gain was considered unremarkable. Gross post mortem observations and lung weights were considered unremarkable. No LD50 value for acute inhalation toxicity could be established and the LD50 value must be greater than the attainable aerosol concentration of hydrogen peroxide of 170 mg/m3.