Naphtha (Fischer-Tropsch), light, C4-10-branched and linear

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

09/84 - 10/84

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Justification for type of information:

The test material 'Naphtha (petroleum), light alkylate' is a closely related substance to 'Naphtha (Fischer-Tropsch), light, C4-10 branched and linear'.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

see below "Principles of method if other than guideline"

Principles of method if other than guideline:

During the study period the relative humidity of the animal room ranged from 60 to 78%. The guideline specified the relative humidity as 30-70%. This deviation is not considered to have had an effect on the validity of this study.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Naphtha (petroleum), light alkylate

EC Number:

265-068-8

EC Name:

Naphtha (petroleum), light alkylate

Cas Number:

64741-66-8

IUPAC Name:

Naphtha (petroleum), light alkylate

Details on test material:

- Name of test material (as cited in study report): Naphtha (petroleum), light alkylate [CAS 64741-66-8]
- Test substance is closely related to Naphtha (Fischer-Tropsch), light, C4-10 - branched and linear; it is defined as : 'A complex combination of hydrocarbons produced by the distillation of the reaction products of isobutane with monoolefinic hydrocarbons usually ranging in carbon numbers from C3 through C5. It consists of predominantly branched chain saturated hydrocarbons having carbon numbers predominantly in the range of C7-C10 and boiling in the range 90-160°C (194-320°F).'

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: approximately 14 weeks
- Weight at study initiation: 2717-3136 g
- Fasting period before study: no data
- Housing: screen-bottom cages
- Diet (e.g. ad libitum): ad libitum (Purina Certified Rabbit Chow f5322)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 14d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-24°C
- Humidity (%): 60-78%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light


IN-LIFE DATES: From: September 26, 1984 To: October 10, 1984

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: back
- % coverage: approximately 10% of the total body surface area
- Type of wrap if used: eight-ply gauze bandage and overwrapped with Saran Wrap and Elastoplast tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed, but wiped clean with wet disposable towels
- Time after start of exposure: 24 hrs


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5.434 - 6.272 g
- Concentration (if solution): 100% (w/w)
- Constant volume: no

Duration of exposure:

24 hrs

Doses:

single dosage level of 2.0 g/kg bw

No. of animals per sex per dose:

4 male and 4 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rabbits were observed for clinical signs and mortality hourly for the first 6 hours after dosing, then
daily for dermal irritation and twice daily for clinical signs and mortality for a period of 14 days. Body weights were taken just prior to administration, at 7 days, and at study termination.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, gross necropsy

Statistics:

none

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

no deaths

Clinical signs:

other: With the exception of dermal irritation, no clinical signs were observed during the study period. A pain response (vocalization) was elicited from all of the animals following application of the test material. Dermal irritation observed during the study r

Gross pathology:

4 male rabbits:
- one animal --> no visible lesions
- one animal --> skin of test site thickened
- two animals --> skin of test site slightly thickened;

4 female rabbits:
- one animal --> skin of test site thickened
- three animals --> no visible lesions

Other findings:

none

Any other information on results incl. tables

Summary of body weights and mortality:

Sex	Dosage Level [g/kg bw]	Average Body Weights (g) Initial Day 7 Terminal			Mortality (number dead / number dosed)
Male	2.0 (Intact)	2.830	2.923	3.140	0/2
Male	2.0 (Abraded)	2.870	2.984	3.232	0/2
Female	2.0 (Intact)	2.829	2.911	3.115	0/2
Female	2.0 (Abraded)	2.931	3.062	3.352	0/2

Summary of clinical signs (number of animals affected - dose level 2000 mg/kg bw):

	Hours						Days
	1	2	3	4	5	6	1	2	3	4	5	6	7	8	9	10	11	12	13	14
Males: appeared normal	4	4	4	4	4	4	4	4	4	4	4	4	4	4	4	4	4	4	4	4
Females: appeared normal	4	4	4	4	4	4	4	4	4	4	4	4	4	4	4	4	4	4	4	4

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal median lethal dose (LD50) of the test material Naphtha (petroleum), light alkylate (EC 265-068-8) in the male and female New Zealand White strain rabbit was estimated to be greater than 2000 mg/kg bodyweight.

Executive summary:

An acute dermal toxicity study with rabbits was performed similar to OECD Guideline 402:

- Mortality: no deaths

- Clinical observations: no signs of systemic toxicity

- Body Weight: within expected gains

- Necropsy: no visible lesions [four of eight animals]; skin of test site (slightly) thickened [four of eight animals]

The acute dermal median lethal dose (LD50) of the test material Naphtha (petroleum), light alkylate in the male and female New Zealand White strain rabbit was estimated to be greater than 2000 mg/kg bodyweight.