Hydrocarbons, C9-C10, aromatics, >1% naphthalene

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

read-across from supporting substance (structural analogue or surrogate)

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:

Hydrocarbons, C9-C10, aromatics, >1% Naphthalene are a combination of Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics. Read across data is available for Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics and the worst case scenario for each end point has been presented.

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Reference

Endpoint:

acute toxicity: dermal

Type of information:

read-across from supporting substance (structural analogue or surrogate)

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:

Hydrocarbons, C9-C10, aromatics, >1% Naphthalene are a combination of Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics. Read across data is available for Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics and the worst case scenario for each end point has been presented.

Reason / purpose for cross-reference:

read-across source

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:

This data is being read across from the source study that tested Hydrocarbons, C9, aromatics based on analogue read across.

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.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

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

Remarks:

Not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Hydrocarbons, C9, aromatics

EC Number:

918-668-5

Molecular formula:

C9H12

IUPAC Name:

Hydrocarbons, C9, aromatics

Test animals

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

Administration / exposure

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.

Results and discussion

Effect levels

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.

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.