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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted according to acceptable scientific conditions, not GLP and no guideline followed. Number of tested animals, dose range, observation time and observed parameters are ok, even if no LD50 was determined.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Cross-reference
Reason / purpose for cross-reference:
read-across: supporting information
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
August 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted according to acceptable scientific conditions, not GLP and no guideline followed. Number of tested animals, dose range, observation time and observed parameters are ok, even if no LD50 was determined.
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 source
Preliminary study:
No data
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 46.4 mL/kg bw
Mortality:
No mortality occurred up to test dose 46.4 mL/kg b.w.
Clinical signs:
Oily secretions in the area of anus from 4.64 mL/kg b.w. up to the highest dose.
Reduced food intake by female at 31.6 mL/kg bw.
No other proof of substance reaction.
Body weight:
10% decrease of female body weight intake at dose 46.4 mL/kg b.w. on first observation day.
Gross pathology:
no specific reaction
Other findings:
Oily secretion in the area of anus for tested dose from 4.64 mL/kg bw to 46.4 mL/kg bw
Decrease in daily food intake :
- at dose 31.6 mL/kg bw, female food intake decreased of 28 % on first observation day and 11 % on 2nd observation day.
- at dose 46.4 mL/kg bw, female food intake decreased of 32 % on first observation day and 49 % on 2nd observation day.

No additional data.

Interpretation of results:
other: no mortality up to 46.4 mL/kg b.w.
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
No mortality was observed in rats up to 46.4 mL/kg b.w., the highest dose tested.
Executive summary:

This data is being read across from the source study that tested Isohexadecane based on analogue read across.

The toxicity of BP Solvent IH/Isohexadecan in Sprague-Dawley rats was tested by gavage of the undiluted liquid test substance as supplied. The animals were observed for 4 weeks after treatment. At the end of observation period, they were killed and a necropsy was performed. The test doses were 2.15, 4.64, 10.0, 21.15, 31.6 and 46.4 mL/kg bw.

Five males and five females were tested at the three lower doses while 10 rats of both sexes were treated at the three higher dose groups. No mortality was observed at any tested dose. Sublethal effects were noted such as oily secretion in the area of anus for tested dose from 4.64 mL/kg bw to 46.4 mL/kg bw. Moreover, 28% and 11% daily food intake decrease was recorded in females treated at 31.6 mL/kg bw on the first and the second day of observation, respectively. The same effects (32% and 49% food intake decreases) were observed at the 24 and 48-hour observation periods in females treated with the highest dose. Decrease of body weight intake was also observed on first observation day in treated females at 46.4 mL/kg bw, corresponding to 37 g/kg bw.

No LD50 was determined.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Principles of method if other than guideline:
Guideline principles
GLP compliance:
not specified
Remarks:
study conducted before GLP
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2,4,4,6,8,8-heptamethylnonane
EC Number:
224-506-8
EC Name:
2,2,4,4,6,8,8-heptamethylnonane
Cas Number:
4390-04-9
Molecular formula:
C16H34
IUPAC Name:
2,2,4,4,6,8,8-heptamethylnonane
Details on test material:
- Name of test material (as cited in study report): BP Solvent IH/Isohexadecan
- Substance type: petroleum product, UVCB
- Analytical purity : 100% commercial product

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Lippische Versuchstierzucht Hagemann GmbH and Co., D-4923 Exertal 1
- Age at study initiation: M: 52 days, F: 70 Days
- Weight at study initiation: Zwischen 165 and 185
- Fasting period before study: 16 hours
- Housing: MAKROLON-Cage (Type III)
- Diet (e.g. ad libitum): fasting during test period
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1.0 °C
- Humidity (%): 60 ± 5 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: August 1980

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE
No vehicle

MAXIMUM DOSE VOLUME APPLIED: 46.4 mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: not provided
Doses:
Doses: 2.15, 4.64, 10.0, 21.15, 31.6 and 46.4 mL/kg b.w:
No. of animals per sex per dose:
Doses: 2.15; 4.64; 10.0 mL/ kg b.w. administered in 5 M + 5 F
Doses: 21.15; 31.6; 46.4 mL/ kg b.w. administered in 10 M + 10 F
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 4 weeks
- Frequency of observations and weighing: every 24 h
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology

- Duration of observation period following administration: 14 days (or other?)
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: feed consumption, behavior, body weight increase
Statistics:
The LD50 was calculated using Litchfield and Wilcoxon method. Mortality rate based on 24h and 14 d was calculated.

Results and discussion

Preliminary study:
No data
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 46.4 mL/kg bw
Mortality:
No mortality occurred up to test dose 46.4 mL/kg b.w.
Clinical signs:
Oily secretions in the area of anus from 4.64 mL/kg b.w. up to the highest dose.
Reduced food intake by female at 31.6 mL/kg bw.
No other proof of substance reaction.
Body weight:
10% decrease of female body weight intake at dose 46.4 mL/kg b.w. on first observation day.
Gross pathology:
no specific reaction
Other findings:
Oily secretion in the area of anus for tested dose from 4.64 mL/kg bw to 46.4 mL/kg bw
Decrease in daily food intake :
- at dose 31.6 mL/kg bw, female food intake decreased of 28 % on first observation day and 11 % on 2nd observation day.
- at dose 46.4 mL/kg bw, female food intake decreased of 32 % on first observation day and 49 % on 2nd observation day.

Any other information on results incl. tables

No additional data.

Applicant's summary and conclusion

Interpretation of results:
other: no mortality up to 46.4 mL/kg b.w.
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
No mortality was observed in rats up to 46.4 mL/kg b.w., the highest dose tested.
Executive summary:

The toxicity of BP Solvent IH/Isohexadecan in Sprague-Dawley rats was tested by gavage of the undiluted liquid test substance as supplied. The animals were observed for 4 weeks after treatment. At the end of observation period, they were killed and a necropsy was performed. The test doses were 2.15, 4.64, 10.0, 21.15, 31.6 and 46.4 mL/kg bw.

Five males and five females were tested at the three lower doses while 10 rats of both sexes were treated at the three higher dose groups. No mortality was observed at any tested dose. Sublethal effects were noted such as oily secretion in the area of anus for tested dose from 4.64 mL/kg bw to 46.4 mL/kg bw. Moreover, 28% and 11% daily food intake decrease was recorded in females treated at 31.6 mL/kg bw on the first and the second day of observation, respectively. The same effects (32% and 49% food intake decreases) were observed at the 24 and 48-hour observation periods in females treated with the highest dose. Decrease of body weight intake was also observed on first observation day in treated females at 46.4 mL/kg bw, corresponding to 37 g/kg bw.

No LD50 was determined.

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