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EC number: 941-379-0 | CAS number: -
- Life Cycle description
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- Endpoint summary
- Appearance / physical state / colour
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- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
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- Endpoint summary
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- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
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- Biotransformation and kinetics
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- Toxicological Summary
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- Acute Toxicity
- Irritation / corrosion
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- Specific investigations
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- Additional toxicological data

Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 494 mg/kg bw/day
Additional information
Data on related substances have been used to 'read-across' and predict the hazard properties. A 'read-across' justification document can be found in section 13.
In a read-across reproductive/developmental toxicity screening study (Klimisch score=1; Schreiner et al., 1997), 10 Sprague Dawley rats/sex/group were treated dermally with hydrodesulfurised kerosine at concentrations of 0 (sham-treated and vehicle control groups), 165, 330 or 494 mg/kg/day (0, 20, 40 or 60% (v/v) respectively) in mineral oil in a dosing volume of 1 mL/kg for a minimum of 6 hours, 7 days/week beginning 14 days premating, during the 14-day mating period and through 20 days of gestation. Rats were mated overnight on a 1:1 ratio and were separated the following morning. Pregnancy was determined by the presence of a vaginal plug or sperm in a vaginal lavage sample. If observed, the female was considered to be at day 0 of gestation. Any female that did not show evidence of mating was placed with the same male the following evening. Any female that did not show evidence of mating at the end of a 2-week mating period was presumed pregnant (gestation day 0 = last day of cohabitation). Skin irritation occurred in both males (all doses) and females (high dose only).
At terminal sacrifice, no findings were reported except for those on the skin. Body weights were unaffected by treatment. However over the course of the 8 weeks, high-dose males gained less weight than the controls. Food consumption was unaffected by treatment. High-dose males had a higher mean relative kidney weight than controls (0.76 vs. 0.66). This was attributed to the lower mean final body weights of the high-dose group. No other organ or organ/body weight changes were recorded. No test-material-related microscopic changes were observed in the testes or epididymides of adult male rats or in the ovaries of adult female rats. No effects were observed on reproductive function or outcome.
There is no parental systemic LOAEL, based on the lack of any significant treatment-related findings except dermal irritation. The parental systemic NOAEL is greater than or equal to 494 mg/kg/day.
There is no offspring LOAEL, based on the lack of any effects noted in the offspring. The offspring NOAEL is greater than or equal to 494 mg/kg/day.
Short description of key information:
Kerosine does not cause fertility effects (OECD 421).
Effects on developmental toxicity
Description of key information
Two relevant studies were identified. In the key dermal study with hydrodesulphurised kerosine, no developmental effects were observed at levels upto 494 mg/kg/day. In a supporting study exposure of rats to kerosine vapour at levels upto 364 ppm did not cause any developmental effects in progeny.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restrictions because it was carried out in a method equivalent/similar to OECD TG 410.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Wilmington, Massachusetts
- Age at study initiation: 12 weeks old
- Weight at study initiation: Not reported
- Housing: Individually in wire cages
- Diet (e.g. ad libitum): ad libitum except during exposure period
- Water (e.g. ad libitum): Not reported
- Acclimation period:13 days
- Route of administration:
- inhalation
- Vehicle:
- air
- Details on exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Dynamic 0.25 cubic metre stainless steel and plexiglass chamber operated under negative pressure
- Method of holding animals in test chamber: Stainless steel and plexiglass chamber
- System of generating vapour: Metering it into a warmed flask and passing compressed air through the flask , then diluted with room air as it entered the chamber
- Temperature, humidity, pressure in air chamber: 21.1 to 23.7 degrees Celsius, humidity not reported, chamber air flow rate was 28.3 litres/minute
- Air flow rate: Not reported
- Air change rate: Not reported
TEST ATMOSPHERE
- Brief description of analytical method used: Hourly samples were analyzed using a Scott Model 216 Hydrocarbon Analyzer previously calibrated with known concentrations of kerosine with methane used as an internal standard
- Samples taken from breathing zone: no
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Intended exposure concentrations were 0, 100, and 400 ppm, 66 to 73 hourly samples were obtained over the course of the exposure period, the average concentrations were 0, 106.4 +/- 10.23, and 364.0 +/- 37.53 ppm, respectively.
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If co-housed:
- M/F ratio per cage: 1 male to 1 female
- Length of cohabitation: Not reported
- Proof of pregnancy: vaginal plug referred to as day 0 of pregnancy - Duration of treatment / exposure:
- Six hours each day
- Frequency of treatment:
- Daily
- Duration of test:
- 10 days from gestational day 6 through gestational day 15
- Remarks:
- Doses / Concentrations:
106 or 364 ppm
Basis:
analytical conc. - No. of animals per sex per dose:
- 20 pregnant females
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale: Only stated that doses were selected by the American Petroleum Institute
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: Gestational days 0, 6, 15, and 20.
FOOD CONSUMPTION: Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 20
- Organs examined: Visceral and thoracic organs
- Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No
- Number of corpora lutea: No
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
- Other: It was only stated that the number of resportion sites were reported. The placement of the implantation sites in the uterine horns were replicated. The number of live and dead fetuses were recorded. - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: one-third of the fetuses
- Skeletal examinations: Yes: two thirds of the fetuses
- Head examinations: Yes: one-third of the fetuses (the same ones that had soft tissue examinations) - Statistics:
- The litter was used as a basic sampling unit for statistical analysis. Dunnett's t-test was used to determine statistical significance (P<0.05) with regard to differences between means with near-normal distribution (body weights and food consumption of dams, mean pup weight based on litter averages). Ratios (nidation index and implantation/corpora lutea ratio) were analyzed with a 2 x 2 contingency table with Yates' correction. Wilcoxon Rank Sum was used for discontinuous parameters as measured by the number of abnormal foetuses within a litter.
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
- Dose descriptor:
- NOAEC
- Effect level:
- >= 364 ppm
- Basis for effect level:
- other: maternal toxicity
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
- Dose descriptor:
- NOAEC
- Effect level:
- >= 364 ppm
- Basis for effect level:
- other: teratogenicity
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Conclusions:
- The NOAEC for both maternal and developmental toxicity was 364 ppm kerosine.
- Executive summary:
In a pre-natal developmental study, 20 female presumed-pregnant rats per group were exposed to 106 or 364 ppm kerosine vapour. Exposures were accomplished in chambers for 6 hours each day on days 6 through 15 of gestation. A control group of 20 presumed-pregnant rats of the same age served as controls and were placed in chambers and exposed to room air only. The rats were weighed on days 0, 6, 15 and 20 of gestation and food consumption was measured throughout the study. The animals were also observed daily for clinical signs. On day 20 of gestation, the animals were anesthetized with chloroform and the visceral and thoracic organs were examined. The uterus was removed and opened and the number of implantation sites and their placement in the uterine horns were recorded. Live and dead foetuses and resorption sites were also recorded and the foetuses were removed, examined externally for abnormalities and weighed. One third of the foetuses was fixed in Bouin's fluid and were examined subsequently for changes in the soft tissues of the head, thoracic and visceral organs. The remaining foetuses were stained with Alizarin red S and examined subsequently for skeletal abnormalities.
There were no effects noted on either the dams of the foetuses. The NOAEC is greater than or equal to 364 ppm, based on the lack of effects and no LOAEC can be determined.
This study received a Klimisch score of 1 and is classified as reliable without restrictions because it was carried out in a method equivalent/similar to OECD TG 410.
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restrictions because it was carried out in a method equivalent/similar to OECD TG 421.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OTS 798.4900 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Charles River Breeding Laboratories, Kingston, New York-
Age at study initiation: Females were approximately 8 weeks old
Weight at study initiation: Females: 183 to 187 grams
Use of restrainers for preventing ingestion (if dermal): yes
Diet (e.g. ad libitum): ad libitum
Water (e.g. ad libitum): ad libitum
Acclimation period: 12 days
ENVIRONMENTAL CONDITIONS
Temperature (°C): 20 to 22
Humidity (%): 40 to 60%
Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light - Route of administration:
- dermal
- Vehicle:
- other: mineral oil (340 SUS)
- Details on exposure:
- TEST SITE
Area of exposure: Entire dorsal back
Type of wrap if used: None
Time intervals for shavings or clippings: Once a week
REMOVAL OF TEST SUBSTANCE
Washing (if done): Washing was only stated to have been done during mating and consisted of wiping the area clean with a piece of gauze.
Time after start of exposure: A minimum of 6 hours
TEST MATERIAL
Amount(s) applied (volume or weight with unit): 1 ml/kg body weight/day
Concentration (if solution): 0, 20%, 40%, or 60% - Constant volume or concentration used: yes
VEHICLE
Justification for use and choice of vehicle (if other than water): Vehicle was used to reduce skin irritation without compromising dermal absorption. Amount(s) applied (volume or weight with unit): 1 ml/kg body weight/day
USE OF RESTRAINERS FOR PREVENTING INGESTION: yes, Elizabethan collars were used. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Details only specify that all test solutions were within +/- 5.42% of the original calculated concentration or of the nominal concentration.
- Details on mating procedure:
- M/F ratio per cage: 1 to 1- Length of cohabitation: Overnight- Proof of pregnancy: Vaginal plug or sperm in vaginal lavage sample referred to as day 0 of pregnancy
- Duration of treatment / exposure:
- Exposure period: 14 days premating to day 20 of gestation.
- Frequency of treatment:
- Daily
- Remarks:
- Doses / Concentrations:
165 (20%), 330 (40%) & 494 (60%) mg/kg/day
Basis:
other: Different concentrations in solution and amount applied - No. of animals per sex per dose:
- Ten
- Control animals:
- yes
- Details on study design:
- Dose selection rationale: Doses were selected based on a two-week range finding study.
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: No
DETAILED CLINICAL OBSERVATIONS: Yes
Time schedule: Twice a day, but once a day on weekends and holidays
BODY WEIGHT: Yes
Time schedule for examinations: Females were weighed on the first day of dosing, weekly thereafter until mating was confirmed, then on gestational days 0, 3, 6, 10, 13, 16, and 20, on postpartum day 0 and 4, and at terminal sacrifice.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No - Details on maternal toxic effects:
- Maternal toxic effects:yes. Remark: skin irritation only
Details on maternal toxic effects:
The only signs of maternal toxicity were skin irritaaion in the highest dose level - Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 494 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
- Remarks on result:
- other: The only signs of maternal toxicity were skin irritaaion in the highest dose level
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
- Dose descriptor:
- NOAEL
- Effect level:
- >= 494 mg/kg bw/day
- Basis for effect level:
- other: developmental toxicity
- Remarks on result:
- other: no developmental effects
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Conclusions:
- Dermal application of hydrodesulphurised kerosine did not cause any developmental effects on progeny.
- Executive summary:
In a reproductive/developmental toxicity screening study, ten male Sprague Dawley rats (aged approximately eight week old, weighing 275-285g) and 10 females (same age and weighing 183-187g) were treated dermally with hydrodesulfurised kerosine at concentrations of 0 (sham-treated and vehicle control groups), 20, 40 or 60% (v/v) in mineral oil in a dosing volume of 1 mL/kg. Dosage equivalents were 0, 165, 330 and 494 mg/kg/day. Test material was applied daily to the shorn skin of the animals 7 days/week beginning 14 days premating, during the 14 day mating period and through 20 days of gestation. Males were treated for an additional week. Collars were fitted to the animals during the dosing period to prevent ingestion of applied materials, but the test site was not covered. After the final dose, the collars were removed and residual test material was wiped from the skin. There were two control groups: the vehicle control was given mineral oil only and in the sham-treated group the animals had been fitted with collars and were stroked with the tip of a syringe, but no material was applied.
During the mating period the test material remained on the animal's backs for at least 6 hours. Prior to pairing, the test material was removed by wiping. Rats were mated overnight on a 1:1 ratio and were separated the following morning. Collars were then reapplied prior to the next dose being applied. Females were monitored for evidence that mating had taken place. Pregnancy was determined by the presence of a vaginal plug or sperm in a vaginal lavage sample. If observed, the female was considered to be at day 0 of gestation. Any female that did not show evidence of mating was placed with the same male the following evening. Any female that did not show evidence of mating at the end of a 2 week mating period was presumed pregnant (gestation day 0 = last day of cohabitation).
Skin irritation among males varied from slight to moderate with increasing dose and was most severe in the high-dose group. Mild to moderate skin irritation was observed in females at the highest concentration. At terminal sacrifice, no findings were reported except for those on the skin. Microscopic changes were found in the skin of males in the vehicle control and all kerosine-treated groups. In females changes were only observed in the high-dose group.
Body weights were unaffected by treatment. However over the course of the 8 weeks, high-dose males gained less weight than the controls. Food consumption was unaffected by treatment. High-dose males had a higher mean relative kidney weight than controls (0.76 vs 0.66). This was attributed to the lower mean final body weights of the high-dose group. No other organ or organ/body weight changes were recorded.
No test-material-related microscopic changes were observed in the testes or epididymides of adult male rats or in the ovaries of adult female rats.
There is no parental systemic LOAEL, based on the lack of any significant treatment-related findings except dermal irritation. The parental systemic NOAEL is greater than or equal to 494mg/kg/day.
There is no offspring LOAEL, based on the lack of any effects noted in the offspring. The offspring NOAEL is greater than or equal to 494 mg/kg/day.
This study received a Klimisch score of 1 and is classified as reliable without restrictions because it was carried out in a method equivalent/similar to OECD TG 421.
Referenceopen allclose all
There
were no compound-related deaths or clinical signs throughout the study.
At necropsy two animals in the 100 ppm group had lung mottling, but this
was considered to be an incidental finding. There were no significant
differences in either body weight or food consumption data. The
following is a summary of reproductive data base on observations of the
uterine contents on day 20 of gestation
Dose (ppm) |
||||
Observation |
Historical control* |
0 |
100 |
400 |
Nidation index (females with implantations/Bred) |
||||
|
55/61 (90.2%) |
19/20 (95%) |
18/20 (90%) |
18/20 (90%) |
Females dying prior to Caesarean section |
|
|||
|
0 |
0 |
0 |
0 |
Live litters |
54 |
19 |
18 |
18 |
Implantation sites (left horn/right horn) |
||||
|
301/363 |
110/118 |
106/138 |
126/114 |
Resorptions |
|
|
|
|
Total |
43 |
18 |
21 |
12 |
Litters |
24 |
11 |
10 |
7 |
Dead foetuses |
||||
Total |
0 |
0 |
0 |
0 |
Litters |
0 |
0 |
0 |
0 |
Mean live litter size (foetuses) |
||||
|
11.3 |
11.1 |
12.4 |
12.7 |
Average foetal weight (g) |
||||
|
4.1 |
4.3 |
4.1 |
3.9 |
|
||||
* Based on 54 litters |
Examination of offspring at delivery did not reveal any
treatment-related abnormalities.
Examination of Bouin's fixed specimens did not reveal any
treatment-related abnormalities.
The sex ratio was also unaffected by treatment.
Skeletal
examinations revealed the following:
Dose group |
No. foetuses examined (number of litters) |
No. Foetuses with normal |
Foetuses |
|
|
|
|
|
common* changes |
unusual skeletal |
|
|
|
|
variations |
|
|
0 |
140 (19) |
60 |
72 (16) |
8 (4) |
|
106.4 |
150 (18) |
69 |
72 (15) |
9 (4) |
|
364 |
154 (18) |
62 |
84 (18) |
8 (5) |
|
*
Foetuses with commonly-encountered changes only. The authors comment
that most of the changes, while not strictly normal, are frequently
observed in 20-day-old rat foetuses of this strain and source in their
laboratory. The changes were not malformations, but were mostly related
to retarded bone ossification. Neither the frequency nor the character
of the changes indicated an adverse effect on foetal growth and
development or a teratogenic potential.
One
pregnant mid-dose female died before delivery. No other animals died or
were prematurely sacrificed and no clinical signs of toxicity were
observed.
Skin irritation among males varied from slight to moderate with
increasing dose and was most severe in the high dose group. Mild
to moderate skin irritation was observed in females at the highest
concentration.
At terminal sacrifice, no findings were reported except for those on the
skin. Microscopic changes were found in the skin of males in the vehicle
control and all kerosine-treated groups. In females changes were only
observed in the high dose group animals. The skin findings (macroscopic
and microscopic) are shown in the following table.
|
Kerosine (mg/kg) |
||||
Parameter |
Control |
Mineral oil |
165 |
330 |
494 |
Males |
|
|
|
|
|
No animals |
10 |
10 |
10 |
10 |
10 |
Max. skin irritation score, sum of means |
|
|
|
|
|
Week of max severity |
- |
2 |
2 |
5 |
5 |
Mean (SD) |
0 |
1.3(1.2) |
2.4(0.7) |
2.5(2.0) |
3.3(2.1) |
Min/max score |
0 |
0/3 |
1/3 |
0/7 |
1/7 |
Gross necropsy observations |
|
|
|
|
|
Crust/scab |
1 |
0 |
0 |
0 |
1 |
Scaly/dry/flaky |
0 |
0 |
1 |
2 |
3 |
Histopathological observations |
|
|
|
|
|
Acanthosis/hyperkeratosis |
2 |
5 |
8 |
7 |
8 |
Hyperplasia, sebaceous glands |
3 |
5 |
5 |
3 |
5 |
Inflammation, dermal |
2 |
1 |
6 |
6 |
7 |
Necrosis, epidermal, focal |
1 |
0 |
1 |
1 |
5 |
Females |
|
|
|
|
|
No animals |
10 |
6 |
10 |
10 |
10 |
Max. skin irritation score, sum of means |
|
|
|
|
|
Week of max severity |
6 |
7 |
3 |
4 |
4 |
Mean (SD) |
0.2 (0.6) |
0.7 (1.0) |
0.4 (0.8) |
1.1 (0.9) |
2.3 (1.8) |
Min/max score |
0/2 |
0/2 |
0/2 |
0/2 |
1/7 |
Gross necropsy observations |
|
|
|
|
|
Crust/scab |
0 |
1 |
1 |
0 |
3 |
Scaly/dry/flaky |
0 |
0 |
0 |
0 |
0 |
Histopathological observations |
|
|
|
|
|
Acanthosis/hyperkeratosis |
3 |
2 |
5 |
5 |
6 |
Hyperplasia, sebaceous glands |
1 |
0 |
0 |
0 |
1 |
Inflammation, dermal |
0 |
1 |
1 |
1 |
4 |
Necrosis, epidermal, focal |
0 |
0 |
0 |
0 |
0 |
Body
weights were unaffected by treatment. However over the course of the 8
weeks, high dose males gained less weight than the controls (201 g
compared to 237g for the sham controls). Food consumption was unaffected
by treatment. High dose males had a higher mean relative kidney weight
than sham controls (0.76 vs 0.66). This
was attributed to the lower mean final body weights of the high dose
group. No other organ or organ/body weight changes were recorded.
Controls |
Kerosine (mg/kg) |
||||
Parameter |
Sham |
Oil |
165 |
330 |
494 |
No animals |
10 |
10 |
10 |
10 |
10 |
Fertility index |
100% |
90% |
90% |
80% |
100% |
Litter with liveborn pups |
10 |
9 |
9 |
7a |
10 |
Corpora lutea |
|
|
|
|
|
Number |
169 |
151 |
158 |
122 |
172 |
Mean |
16.9 |
16.8 |
17.6 |
17.4 |
17.2 |
(SD) |
(1.9) |
(2.4) |
(2.0) |
(0.8) |
(2.9) |
Implantation sites |
|
|
|
|
|
Number |
163 |
149 |
155 |
118 |
167 |
Mean |
16.3 |
16.6 |
17.2 |
16.9 |
16.7 |
(SD) |
(1.9) |
(2.4) |
(1.8) |
(1.3) |
(2.8) |
Pups delivered |
|
|
|
|
|
Total |
152 |
131 |
147 |
109 |
150 |
Mean |
15.2 |
14.6 |
16.3 |
15.6 |
15.0 |
(SD) |
(2.0) |
(2.7) |
(2.3) |
(2.9) |
(2.9) |
Liveborn |
152 |
130 |
143 |
108 |
148 |
Livebirth index |
100% |
99% |
97% |
99% |
99% |
Pups dying |
|
|
|
|
|
day 0 |
3 |
0 |
1 |
1 |
1 |
days 1-4 |
2 |
4 |
1 |
1 |
9bc |
Pups surviving |
|
|
|
|
|
4 days |
147 |
126 |
141 |
106 |
138 |
Viability index |
97 |
97 |
99 |
98 |
93c |
Pup weight/litter (g) |
|
|
|
|
|
day 1 mean |
6.9 |
6.8 |
7.0 |
7.0 |
6.7 |
day 4 mean |
9.9 |
9.6 |
10.1 |
9.9 |
9.8 |
a one
dam died on gestation day 21; the cause of death was unrelated to
treatment
b significantly
different from control (P<0.05)
c One
dam had a malfunctioning water bottle; when 4 dead pups from this litter
are excluded from the analysis, no
significant difference from control was found.
No test-material-related microscopic changes were observed in the testes
or epididymides of adult male rats or in the ovaries of adult female
rats.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 364
- Species:
- rat
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 494 mg/kg bw/day
Additional information
In a key reproductive/developmental toxicity screening study (Klimisch score=1; Schreiner, et al., 1997), 10 Sprague Dawley rats/sex/group were treated dermally with hydrodesulfurised kerosine at concentrations of 0 (sham-treated and vehicle control groups), 165, 330 or 494 mg/kg/day (0, 20, 40 or 60% (v/v), respectively) in mineral oil in a dosing volume of 1 ml/kg for a minimum of 6 hours,7 days/week beginning 14 days premating, during the 14-day mating period and through 20 days of gestation. Dosage equivalents were 0, 165, 330 and 494 mg/kg/day. There is no offspring LOAEL, based on the lack of any effects noted in the offspring. The offspring NOAEL is greater than or equal to 494 mg/kg/day. This was the highest dose tested in the study.
In a supporting pre-natal developmental study (Klimisch score=1; API, 1979b), 20 female presumed-pregnant rats per group were exposed to 106 or 364 ppm kerosine vapour for 6 hours each day on days 6 through 15 of gestation. A control group of 20 presumed-pregnant rats of the same age served as controls and were placed in chambers and exposed to room air only. The animals were sacrificed on day 20 of gestation. There were no effects noted on either the dams or the foetuses. The NOAEC is greater than or equal to 364 ppm, based on the lack of effects and no LOAEC can be determined.
Justification for selection of Effect on developmental toxicity: via inhalation route:
well conducted inhalation study in rats on kerosine
Justification for classification or non-classification
Available data indicate that kerosine has no effect on the fertility of male and female rats and does not cause developmental effects. Therefore kerosines are not classified for reproductive or developmental toxicity according to EU CLP Regulation (EC No. 1272/2008).
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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