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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:
3 - 23 September 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study. Only single test concentration used.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): SBP 100/140. A mixture of hydrocarbon liquids. SICC code: Q 5811
- Substance type: colourless liquid
- Physical state: liquid
- Analytical purity: 100% pure commercial product
- Stability under test conditions: yes
- Storage condition of test material: room temperature in original container
- Other: supplied by sponsor

Before the current ECHA nomenclature rules became effective, we adopted the IUPAC name Hydrocarbons, C7-9, n-alkanes, isoalkanes, cyclics (EC number 920-750-0) as the identifier for the substance and this was the name that was used during the pre-registration phase of REACH. Also during this time, samples of the product were collected and the required physicochemical studies were conducted. The resulting robust studies summaries were entered into the IUCLID dossier using this name and EC number.

Between 2008 and 2009 ECHA issued a specific document about the nomenclature to be used under REACH, the so called REACH Implementation Project 3.10. The implications of this document to the appropriate nomenclature for the registered substance were only fully understood by us beginning in late 2009/early 2010.

As such, during the creation of the robust study summaries in IUCLID, the discrepancy with the substance naming was not noticed. As a result, it appears in IUCLID that the tested substance indicated is not the same as the registered one; however, if robust study summaries and/or associated study reports use the substance name “Hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics,” they are actually referring to the registered substance “Hydrocarbons, C7-C8, n-alkanes” according to the revised REACH nomenclature rules.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK Ltd., Abbots Ripton Road, Wyton, Huntingdon
- Age at study initiation: 6 weeks (male), 8 weeks (female), different ages selected so that both sexes are of same body weight
- Weight at study initiation: 200 g
- Housing: polypropylene cages (38 x 56 x 18 cm) with wire meshes on tops and floors
- Diet (e.g. ad libitum): measured excess amount of food (Labsure LAD 1)
- Water (e.g. ad libitum): measured excess amount of tap water



ENVIRONMENTAL CONDITIONS
- Temperature (°C): mean daily maximum: 25°C (SD 1.3), mean daily minimum: 21°C (SD 0.6)
- Humidity (%): mean relative humidity: 60% (SD 6.4)

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: all parts were made of perspex
- Exposure chamber volume: 120 liters
- Method of holding animals in test chamber: Chamber divided by wire mesh partitions to provide 10 seperate animal compartments
- Source and rate of air: flow rate fo 25 L per minute; air warmed to 30°C to assist vaporisation of test substance. For the exposure a 50 mL syringe filled with the test substance was fitted to the syringe pump and connected to the atomiser with PTFE tubing. A flow rate of approx. 0.9 mL per minute was selected for the exposure. This flow rate was expected to give a concentration of vapour in excess of 20 mg/L of air. The syringe pump was switched on and the exposure timed for 4 hours, following an 11-minute equilibration period (total exposure time 4 hours 11 minutes). The syringe was refilled as required during the exposure.
- Method of conditioning air: The compressed air supply to the generator was dried, filtered and oil-free
- Temperature, humidity, pressure in air chamber: mean of 25.4°C in control and test


TEST ATMOSPHERE
- Brief description of analytical method used: 5 air samples were taken from the chamber during each exposure and analysed to determine the concentration of the test substance in the chamber atmosphere. The samples were drawn through a gas absorption trap, containing approximately 20 mL of acetone and cooled to -70°C in acetone/dry ice(=refrigerant). The sampling rate was 2 liters per minute and the volume of air sample was measured with a wet-type gas meter. One additional sample was taken using a Royco 218 particle size analyser to confirm the absence of droplets.
Analytical verification of test atmosphere concentrations:
yes
Remarks:
GLC
Duration of exposure:
4 h
Concentrations:
mean of 23.3 mg/L of air
No. of animals per sex per dose:
5 males, 5 females
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed continuously during exposure and at least twice daily during observation period. Weighed daily from the day of delivery to the end of the observation period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 23.3 mg/L air
Exp. duration:
4 h
Mortality:
One male died during exposure at approximately 2 hours from the start of exposure
Clinical signs:
other: Partial closing of the eyes, restless behaviour and a reduced respiration rate were the main clinical signs evident during exposure. The signs were considered to be consistent with exposure to a slightly irritant vapour. Other signs seen during exposure w
Body weight:
All rats exposed lost weight or had a reduced rate of bodyweight gain for 1-2 days following exposure. Subsequently the rate of bodyweight gain for exposed rats was similar to that of the control rats.
Gross pathology:
Findings for the rat that died following exposure were congestion of the lungs, yellow frothy fluid in the trachea and gas-filled stomach and gastro-intestinal tract
Other findings:
Food consumption was reduced for 1 day following exposure. Water consumption was not affected.

Histopathology: Marked pulmonary congestion and focal alveolar haemorrhage in the single deceased rat. Significance of this finding is uncertain.

Any other information on results incl. tables

Table: Mean Bodyweights (g)

Day

Female Control

Female Test

Male Control

Male Test

-5

174

179

153

148

-4

183

186

164

164

-3

189

185

172

176

-2

194

191

187

194

-1

198

197

196

201

0

203

202

203

211

1

203

199

211

212

2

205

201

222

219

3

213

211

229

232

4

214

212

237

242

5

216

209

240

249

6

219

211

248

255

7

221

212

259

264

8

228

215

273

282

9

230

226

276

285

10

234

227

285

295

11

242

234

297

307

12

242

238

300

315

13

244

238

303

319

14

246

239

308

324

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: GHS, EU, 2007
Conclusions:
The purpose of the is study was to examine the inhalation toxicity of hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics to rats. 5 male and 5 female rats were exposed to a concentration of 23.3 mg/L of test substance in the air for 4 hrs. Animals were examined at 0, 0.25, 0.5, 1, 2, 3, and 4 hrs after start of exposure for clinical signs and mortality. Animals were also examined daily for the next 14 days. Animals were weighed daily. Animals were examined for gross pathology and histopathology either after death, or after sacrifice at the end of the experiment. One male rat died during the experiment. The LC50 is > 23.3 mg/L of air. The test substance is not classified as toxic under the OECD GHS guidelines.
Executive summary:

The purpose of the is study was to examine the inhalation toxicity of hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics to rats. 5 male and 5 female rats were exposed to a concentration of 23.3 mg/L of test substance in the air for 4 hrs. Animals were examined at 0, 0.25, 0.5, 1, 2, 3, and 4 hrs after start of exposure for clinical signs and mortality. Animals were also examined daily for the next 14 days. Animals were weighed daily. Animals were examined for gross pathology and histopathology either after death, or after sacrifice at the end of the experiment. One male rat died during the experiment. The LC50 is > 23.3 mg/L of air. The test substance is not classified as toxic under the OECD GHS guidelines.