Hydrocarbons, C10, aromatics, <1% naphthalene

Endpoint summary

Description of key information

Acute Oral LD₅₀ = 3492 mg/Kg in rats (OECD TG 401)

Acute Dermal LD₅₀ >3160 mg/Kg in rabbits (OECD TG 402)

Acute Inhalation LC₅₀ >6193 mg/m³ in rats (OECD TG 403)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given: comparable to guidelines/standards.

Justification for type of information:

A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

no guideline followed

Principles of method if other than guideline:

2 male and 2 female rats dosed with 1, 2, 4, or 8 ml/kg of test substance via oral gavage.

GLP compliance:

no

Remarks:

prior to GLP

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

other: Charles River CD

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 12 weeks
- Fasting period before study: overnight
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Route of administration:

oral: gavage

Doses:

1, 2, 4, 8 ml/kg

No. of animals per sex per dose:

2

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 9 days
- Frequency of observations and weighing: daily
- Other examinations performed: clinical signs

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 8 mL/kg bw

Remarks on result:

other: (~6984) mg/kg/bw)

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

4 mL/kg bw

Remarks on result:

other: (~3492 mg/kg/bw)

Mortality:

One female at the 4 ml/kg dosage died on day 7 of the study. The two females given dosages of 8 ml/kg died on day 7 of the study. No males at any dosage level died during the study.

Clinical signs:

other: One female from the 8 ml/kg dosage group became ataxic on day 4, a condition that persisted until the death of the animal on day 7.

Interpretation of results:

other: Not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The LD50 for female rats was 4 ml/kg bw. The LD50 for male rats was > 8 ml/kg (6984 mg/kg/bw). Given the relative density of 0.873 g/ml for the test substance, the LD50 for female rats is equivalent to 3492 mg/kg bw, at which level the test substance is considered not classifiable.

Executive summary:

This study was conducted to determine the acute oral toxicity of Hydrocarbons, C9, aromatics to rats. 2 male and 2 female rats dosed with 1, 2, 4, or 8 ml/kg of test substance via oral gavage. One female rat in the 4 ml/kg exposure group died, and both females in the 8 ml/kg exposure group died after showing signs of lethargy and ataxia. None of the male rats in the study died. The LD50 for female rats is then 4 ml/kg. The LD50 for male rats is > 8 ml/kg (6984 mg/kg bw). According to EU GHS guidelines, the test substance is not classified as being toxic.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

3 492 mg/kg bw

Quality of whole database:

One key read across study available for assessment.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Reference 1

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.

Justification for type of information:

A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

equivalent or similar to guideline

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

Species:

rat

Strain:

other: Crl: CDBR

Sex:

male/female

Details on test animals or test system 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

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.

Key result

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:

other:

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.

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

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.

Reference 2

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Done in accordance to basic scientific principles.

Justification for type of information:

A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

not specified

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River
- Age at study initiation: 7-8 weels
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

Two rats of each sex age 7and 8 weeks were housed in a tubular glass chamber, and exposed for 4 hours to test atmospheres by the near saturation of air supplied to the test chamber. The animals were observed over the subsequent 14 days. Food and water were available to the animals at all times except for the 4 hour exposure period.

The concentration of solvent in the test atmosphere was monitored continuously during the exposure by means of a high temperature total hydrogen analyzer. The instrument was calibrated using a gravimetric procedure.

Analytical verification of test atmosphere concentrations:

yes

Remarks:

high temperature total hydrogen analyzer

Duration of exposure:

4 h

Concentrations:

10.2 mg/L (approx 2000 ppm)

No. of animals per sex per dose:

two rats of each sex

Control animals:

no

Details on study design:

Two rats of each sex age 7and 8 weeks were housed in a tubular glass chamber, and exposed for 4 hours to test atmospheres by the near saturation of air supplied to the test chamber. The animals were observed over the subsequent 14 days. Food and water were available to the animals at all times except for the 4 hour exposure period.

The concentration of solvent in the test atmosphere was monitored continuously during the exposure by means of a high temperature total hydrogen analyzer. The instrument was calibrated using a gravimetric procedure.

Statistics:

none

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 10.2 mg/L air (nominal)

Remarks on result:

other: (approx 2000 ppm)

Mortality:

No mortality was noted.

Clinical signs:

other:

Interpretation of results:

other: Not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The LC50 was >10.2 mg/l (approx 2000 ppm). The LC50 for acute inhalation exposure to the test material vapor is greater than the highest obtainable vapor concentration. Classification as an acute inhalation toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Executive summary:

The acute inhalation toxicity of the test material was evaluated in four CD rats.  Animals were exposed for four hours to the maximum attainable vapor concentration of the test material >10.2 mg/l (approx 2000 ppm) in individual inhalation chambers.  Animals were observed for 14 days.  There were no mortality or gross pathological alterations noted in any of the animals.  Based on the conditions of this study, the LC50 for vapors of Hydrocarbons, C9 Aromatics are greater than >10.2 mg/l (approx 2000 ppm). Classification as an acute inhalation toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

6 193 mg/m³ air

Quality of whole database:

Two key read across studies available for assessment.

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984/03/01-1984/03/15

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Similar to OECD Guideline 402: Acute Dermal Toxicity

Justification for type of information:

A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

Used 3 male and 3 female rabbits instead of recommended 5 for each sex; occlusive patch used

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hazelton Dutchland, Inc.
- Sex: male (3), female (3)
- Age at study initiation: appox. 19 weeks
- Weight at study initiation: 2,99-3.61 kg
- Housing: Individually
- Diet (e.g. ad libitum): Purina certified rabbit chow HF, ad libitum
- Water (e.g. ad libitum): Automatic watering system, ad libitum
- Acclimation period: 52 days


ENVIRONMENTAL CONDITIONS
- Temperature (°F): 65-71
- Humidity (%): 40-70
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Dorsal surface
- Type of wrap if used: gauze patch covered with a plastic sleeve


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Distilled water and paper towels
- Time after start of exposure: 24 hrs


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3160 mg/kg
- Concentration (if solution): Assumed to be 100%; density of 0.8578 g/ml
- Constant volume or concentration used: yes

Duration of exposure:

24 hrs

Doses:

one dose: 3160 mg/kg
volume: 11-13 ml

No. of animals per sex per dose:

3 males, 3 females

Control animals:

no

Details on study design:

SCORING SYSTEM: Draize scale
- Duration of observation period following administration: 2, 4, 24 hrs after dosing and once per day thereafter for 14 days
- Dermal response observations: 24 hrs, 3, 7, 10, and 14 days
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight

Statistics:

The mean and standard deviations for the body weights and body weight changes were calculated.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 160 mg/kg bw

Mortality:

There were no animal deaths prior to study termination.

Clinical signs:

other: Overall low incidence of clinical in-life observations. -Most frequently noticed: desquamation, atonia, leathery skin, and eschar. At the termination of the study all animals exhibited desquamation. -Low Incidences: soft stool and small amount of stool,

Gross pathology:

All animals displayed very slight to well-defined erythema from day 0 to day 7. By day 14, only two animals still showed erythema; one having a very slight grade noted. Many animals exhibited very slight edema in a similar time frame.

Desquamation (6 animals), atonia (2 animals), leathery skin (2 animals), and eschar (1 animal) were noted through out the observational time period. At the termination of the study all animals exhibited desquamation.

Two animals were noted as being hyperactive and having a red nasal discharge after dosing. There was a single incidence of slight vocalization following dosing.

Other findings:

GROSS POSTMORTEM EXAMINATION
Alopecia for 1 animal (abdominal).
Severe erythema for 1 animal at the dosing site.
Desquamation for all animals at the dosing site.

Summary of other acute dermal 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

8.5.3 Acute toxicity, dermal route

7.2.3

Acute percutaneous toxicity

rat

Experimental result

According to

Noakes, D.N., and Sanderson, D.M. (1969). A method for determining the dermal toxicity of pesticides. Br. J. Industr. Med.,26, 59-64.

2

Summary only of study.

No data

Shellsol A

LD50 > 4 ml/kg

Study report

Coombs, AD, Blair, D, Doak, SM, Carter, BI

1977

The Acute Toxicity of Shellsol A

HSPA0692

Sittingbourne Research Centre

M(T)-1-77

Shell Chemicals Europe BV

June, 1977

yes

Interpretation of results:

other: Not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The LD50 > 3160 mg/kg based on these data, MRD-83-208 is not classified under EU requirements for dangerous substances and preparations. MRD-83-208 is also not classified under GHS guidelines.

Executive summary:

Three male and female rabbits were exposed to MRD-83 -208 for 24 hrs via an occluded patch. Dermal evaluations occurred at 24 hrs post patch removal and on days 3, 7, 10, 14. Exposure had no affect on viability; all animals survived the exposure. It is concluded that the LD50 in this situation is greater than 3160 mg/kg. MRD-83 -208 is not classified under EU dangerous substances and preparations guidelines. MRD-83 -208 is also not classified under GHS guidelines.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

3 160 mg/kg bw

Quality of whole database:

One key read across study available for assessment.

Additional information

There is no data available for Hydrocarbons, C10, aromatics, <1% naphthalene. However, data is available for structural analogues, Hydrocarbons, C9 aromatics and Hydrocarbons, C10 aromatics and presented in the dossier. This data is read across to based on analogue read across and a discussion and report on the read across strategy is provided as an attachment in IUCLID Section 13.

Acute Oral Toxicity

 

Hydrocarbons, C9, aromatics

A key study (Shell, 1977a) was conducted to determine the acute oral toxicity of Hydrocarbons, C9, aromatics in rats. 2 male and 2 female rats were dosed with 1, 2, 4, or 8 mL/Kg of test substance via oral gavage. One female rat in the 4 mL/Kg exposure group died, and both females in the 8 mL/Kg exposure group died after showing signs of lethargy and ataxia. None of the male rats in the study died. The LD₅₀ for female rats is then 4 mL/Kg. The LD50 for male rats is > 8 mL/Kg (6984 mg/Kg bw). According to EU GHS guidelines, the test substance is not classified as being toxic.

 

Acute Inhalation Toxicity

Hydrocarbons, C9, aromatics

In a key acute inhalation toxicity study (ExxonMobil, 1996), five male and five female rats were exposed to 6193 mg/m³(>6.193 mg/L) air vapors of the test material (Hydrocarbons, C9, aromatics) 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, the test substance Hydrocarbons,C9 aromatics is not classified under either the EU GHS guidelines as the LC50 level exceeds the maximally attainable vapor concentrations under the test conditions.

 

In another key study (Shell, 1976), the acute inhalation toxicity of the test material (Hydrocarbons, C9, aromatics) was evaluated in four CD rats. Animals were exposed for four hours to the maximum attainable vapor concentration of the test material >10.2 mg/L (approx 2000 ppm) in individual inhalation chambers. Animals were observed for 14 days. There were no mortality or gross pathological alterations noted in any of the animals. Based on the conditions of this study, the LC₅₀for vapors of Hydrocarbons, C9 Aromatics are greater than >10.2 mg/L (approx 2000 ppm). Classification as an acute inhalation toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).

Hydrocarbons, C10, aromatics

In a supporting acute inhalation toxicity study (Carpenter et al. 1977), the LC₅₀s reported for Hydrocarbons, C10, aromatics were >6.3 mg/L in rats; >8.2 mg/L in cats; and >1 mg/L in dogs. Classification as an acute inhalation toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).

 

Acute Dermal Toxicity

Hydrocarbons, C9, aromatics

In a key acute dermal toxicity study (ExxonMobil, 1984), three male and female rabbits were exposed to the test material (Hydrocarbons, C9, aromatics) for 24 hrs via an occluded patch. Dermal evaluations occurred at 24 hrs post patch removal and on days 3, 7, 10, 14. Exposure had no affect on viability; all animals survived the exposure. It is concluded that the LD₅₀ in this situation is greater than 3160 mg/Kg. Hydrocarbons, C9, aromatics is not classified under EU dangerous substances and preparations guidelines. Hydrocarbons, C9, aromatics is also not classified under GHS guidelines.

Justification for classification or non-classification

Based on the available read across data, Hydrocarbons, C10, aromatics, <1% naphthalene does not warrant classification as an acute oral, dermal, or inhalation toxicant under the new Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP). On the basis of available physical and chemical property data (hydrocarbon fluid, viscosity ≤ 20.5 mm²/s), Hydrocarbons, C10, aromatics, <1% naphthalene is classified under EU CLP guidelines as a Category 1 aspiration hazard (H304).