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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1996/02/01-1996/02/15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Equivalent or similar to OECD Guideline 403. GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
5 animals used per species (not 10); dry air stream used to generate vapors so no particulate analysis was done
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Crl: CDBR
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories Inc.
- Sex: Male (5), Female (5) for each species
- Age at study initiation: 7 weeks
- Weight at study initiation: male 214-242g, female 170-214g
- Housing: Single housed
- Diet (e.g. ad libitum): PMI Feeds, Inc. Certified Rodent Diet #5002 ad libitum during nonexposure period; withheld during exposure
- Water (e.g. ad libitum): automatic watering system, ad libitum
- Acclimation period: 14 d and animals were examined once a day for viability


ENVIRONMENTAL CONDITIONS
- Temperature (°F): 68-76
- Humidity (%): 40-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
The test material was heated to 137ºC to generate the vapor and resulting vapors were mixed with room air as both were drawn up through the generator and into the exposure chamber.
Analytical verification of test atmosphere concentrations:
yes
Remarks:
a calibrated infrared vapor analyzer
Duration of exposure:
4 h
Concentrations:
Exposure Concentration (average actual): 6193 mg/m³
Exposure Concentration (nominal): 6528 mg/m³
Chamber size: 150 l
ATM pressure: slightly negative pressure to the room
Temperature: 25 deg C
Air flow rate: 30 (L/min)
No. of animals per sex per dose:
Male (5), Female (5) for each species
Control animals:
no
Details on study design:
The animals were individually housed in a 150l stainless steel whole body inhalation chamber that was under a slight negative pressure to the room and had an air flow of 30 (l/min). The exposure was 4 hrs plus equilibration time (~23 min) and air flow, temperature, and humidity were continuously monitored. Animals were observed for mortality and obvious toxic signs at 15 min intervals for the first hour of exposure and then once each hour until the termination of the exposure. Body weights for each animal were recorded prior to exposure and on days 7 and 14. A gross necropsy was performed on every animal.
Statistics:
Mean and standard deviation of body weight and body weight change by group and sex.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 6 193 mg/m³ air (analytical)
Remarks on result:
other: Concentration tested was the maximally attainable vapor concentration.
Mortality:
None
Clinical signs:
No adverse reactions were noted during exposure or the 14-day observation period that followed except for one female which had scabs on the head from day 4-9.
Body weight:
All animals gained body weight at the 7 and 14 day observation periods.
Gross pathology:
Necropsy examinations performed on all animals at the end of the observational period did not reveal any gross pathological alterations.

Any other information on results incl. tables

Summary of other acute inhalation toxicity studies.

End Point Study Reference  
REACH requirement IUCLID Section Study Name Data Waiving Waiving Justification Species Study Result Type Test Guideline/Qualifier Test Guideline/Guideline Test Guideline/Deviations Reliability Rational For Reliability GLP Compliance Test Materials/Identity Study Result Reference Type Reference Author Reference Year Reference Title Bibliographic Source Testing Laboratory Reference Report No. Owner Company Company Study No. Report Date Data access
8.5.2 Acute toxicity inhalation 7.2.2 Inhalation rat Experimental result No guideline followed. 2 Summary only of study. No data     Shellsol A LC50 > 10.2 mg/L Study report Coombs, AD, Blair, D, Doak, SM, Carter, BI 1977 The Acute Toxicity of Shellsol A HSPA0690 Sittingbourne Research Centre M(T)-1-77 Shell Chemicals Europe BV June, 1977 yes
8.5.2 Acute toxicity inhalation 7.2.2 Acute Vapor Inhalation Toxicity Study - Albino Rats, Mice and Guinea Pig  rat, mice, guinea pig Experimental result Equivalent or similar to  OECD guideline 403 5 animals used per species (not 10); dry air stream used to generate vapors so no particulate analysis was done.  2 The study is scientifically sound, however, it was not performed in strict accordance with OECD guidelines.  No    MRD-ECH-74-22 LC50 > 14.4 mg/L Study report ANON 1975 Acute Vapor Inhalation Toxicity Study - Albino Rats, Mice and Guinea Pig  HSPA0153 Industrial BioTest Laboratories, Inc. 663-06262 ExxonMobil Petroleum & Chemical BVBA 75MRL17 27/03/1975 yes
8.5.2 Acute toxicity inhalation 7.2.2 The Acute 4 H Inhalation LC50 of Hydrogenated Shellsol A in Rats rat Experimental result No guideline followed. 1 Well-documented study. No Hydrogenated Shellsol A LC50 =14.0 mg/L Study report Blair, D 1982 The Acute 4 H Inhalation LC50 of Hydrogenated Shellsol A in Rats HSPA0691 Sittingbourne Research Centre Shell Chemicals Europe BV SBGR.82.037 Jan. 1982 yes

Applicant's summary and conclusion

Interpretation of results:
other: not classifiable
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The LC50 was > 6193 mg/m³ (>6.193 mg/l) air. Based on the LC50 and other data, test substance MRD-95-374 is not classified under either the EU GHS guidelines or under the EU dangerous substances and preparations guidelines as the LC50 level exceeds the maximally attainable vapor
concentrations under the test conditions.
Executive summary:

Five male and five female rats were exposed to 6193 mg/m3 (>6.193 mg/l) air vapors of test material MRD-95-374 for 4 hrs. Animals were observed for 14 days. Animals continued to gain weight through day 14. There was no mortality and no gross pathological alterations noted in any of the animals. Based on an LC50 >6193 mg/m3 (>6.193 mg/L) air and other data, test substance Hydrocarbons,C9 aromatics is not classified under either the EU GHS guidelines or under the EU dangerous substances preparations guidelines as the LC50 level exceeds the maximally attainable vapor concentrations under the test conditions.