C8-C26 branched and linear hydrocarbons – Distillates

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

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

Adequacy of study:

key study

Study period:

02/1996 - 11/1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted on supporting substance (with limited range, C8-C12) in compliance with GLP; acceptable, well-documented study report which meets basic scientific principles

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OTS 798.1100 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

unknown

IUPAC Name:

unknown

Constituent 2

Reference substance name:

Kerosine (Fischer-Tropsch), limited-range, C8-12 - branched and linear

IUPAC Name:

Kerosine (Fischer-Tropsch), limited-range, C8-12 - branched and linear

Details on test material:

- Substance type: Organic
- Physical state: Liquid
- Analytical purity: 100%
- Impurities (identity and concentrations): Information not available
- Isomers composition: Information not available
- Purity test date: December 06, 1995
- Expiration date of the lot/batch: Information not available
- Stability under test conditions: Stable under normal temperature and pressure
- Storage condition of test material: Under cool conditions (approximately 4°C)

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: male animals were approximately 7 - 8 weeks, the females approximately 10 - 11 weeks old
- Weight at study initiation: 208 - 240 g for males and 212 - 232 g for females
- Fasting period before study: none
- Housing: stainless steel grid cages; on completion of dosing, the animals were accommodated in individual cages
- Diet (e.g. ad libitum): ad libitum [pelleted rodent diet (RM1 (E)]
- Water (e.g. ad libitum): ad libitum (tap water)
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23.5
- Humidity (%): 46-52
- Air changes (per hr): at least 10 complete air changes per hour without recirculation
- Photoperiod (hrs dark / hrs light): 12 / 12


IN-LIFE DATES: From: approximately December 1995 (female)/ January 1996 (male) To: 07 March 1996

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: body surface area
- % coverage: 5 cm x 5 cm area (approximately 10% of the body surface area)
- Type of wrap if used: 5 cm x 5 cm gauze patch, occluded with aluminium foil; the foil was kept in place and protected by a pad of cotton wool and a bandage of waterproof plaster and tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the dermal site was gently wiped with wet disposable tissues to remove residual test material
- Time after start of exposure: 24 hours after administration


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): not available - quantity of dose was determined for each animal according to its bodyweight
- Constant volume used: no


VEHICLE
none

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 male and 5 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- observations: three separate recordings of signs were made during the first hour after administration and two further recordings during the
remainder of Day 1; from Day 2 onwards, the animals were inspected twice daily and recordings of systemic and local signs were made once daily
- weighing: on days 1, 8 and 15
- Necropsy of survivors performed: yes

Statistics:

none

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

no death

Clinical signs:

other: no local or systemic sign of reaction to treatment

Gross pathology:

necropsy revealed no significant macroscopic lesion

Other findings:

none

Any other information on results incl. tables

1) Bodyweights(Dosage 2000mg/kg bw):

	Bodyweight [g]
	Male-1	Male-2	Male-3	Male-4	Male-5
Day -1	227	226	208	240	239
Day 1	232	238	214	246	248
Day 8	259	278	227	285	281
Day 15	296	331	264	337	323
Increment	69	105	56	97	84
Mean of Increment					82

	Bodyweight [g]
	Female-1	Female-2	Female-3	Female-4	Female-5
Day -1	232	217	212	221	231
Day 1	237	221	215	225	234
Day 8	252	238	244	235	244
Day 15	265	253	237	255	280
Increment	33	36	25	34	49
Mean of Increment					35

2) Necropsy observations(Dosage 2000 mg/kg bw):

Animal and sex	Died or Sacrificed	Time of death	Necropsy observations
Male-1	Sacrificed	Day 15	External Application site: No significant lesion Other: No significant lesion Internal No significant lesion
Male-2	Sacrificed	Day 15
Male-3	Sacrificed	Day 15
Male-4	Sacrificed	Day 15
Male-5	Sacrificed	Day 15
Female-1	Sacrificed	Day 15	External Application site: No significant lesion Other: No significant lesion Internal No significant lesion
Female-2	Sacrificed	Day 15
Female-3	Sacrificed	Day 15
Female-4	Sacrificed	Day 15
Female-5	Sacrificed	Day 15

3) Systemic and local signs (Dosage 2000 mg/kg bw):

	Number of animals showing signs+
	Male	Female
No abnormality detected	5	5
Total number of survivors	5	5

+ Five animals in each sex-group

4) Mortality (Dosage 2000 mg/kg bw):

	Mortality
	Male	Female	Combined
Dosage 2000 mg/kg bw	0/5	0/5	0/10

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

There was no death and no local or systemic sign of reaction to treatment. All animals achieved anticipated bodyweight gains and necropsy revealed
no significant macroscopic lesion. Under the conditions of this study, the acute dermal median lethal dosage (LD50) of the test material 'Kerosine (Fischer-Tropsch), limited-range, C8-12 - branched and linear' was greater than 2000 mg/kg. According to Annex VI of Council Directive 67/548/EEC 'Kerosine (Fischer-Tropsch), limited-range, C8-12 - branched and linear' should be unclassified with regards to acute dermal toxicity. Using the EU Globally Harmonised System (GHS), it would be also ‘unclassified’. Finally, the analogue 'Distillates (Fischer-Tropsch), C8-26-branched and linear' also should not be classified.

Executive summary:

According to EU-Method B.3 the acute dermal toxicity of 'Kerosine (Fischer-Tropsch), limited-range, C8-12 - branched and linear'

, a structural analogue to 'Distillates (Fischer-Tropsch), C8 -26 - branched and linear`, was investigated in a group of five male and five female CD rats. The test material was applied to the closely-clipped dorsum of each animal at a dosage of 2000 mg/kg bodyweight, and was covered by an occlusive dressing for 24 hours.

Mortality, systemic and local signs of reaction to treatment were recorded during a subsequent 14-day period of observation. The animals were killed on the following day and subjected to necropsy.

There was no death and no local or systemic sign of reaction to treatment. All animals achieved anticipated bodyweight gains and necropsy revealed no significant macroscopic lesion. Under the conditions of this study, the acute dermal median lethal dosage (LD50) of the test material was greater than 2000 mg/kg bw. Finally, the acute dermal median lethal dosage (LD50) of the structural analogue 'Distillates (Fischer-Tropsch), C8 -26 - branched and linear` also should be greater than 2000 mg/kg bw.