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Administrative data

Description of key information

Acute Oral Toxicity

The key study examined the acute oral toxicity of Benzene, mono-C10-13-alkyl derivs., distn. residues (HAB) to rats. A group of 5 male and 5 female rats were given a dose of 2000 mg/kg bw test substance. The animals were examined for clinical symptoms and mortality at 0.5, 1, 2, 3, 4, 5, and 6 hours after application, and then once a day for two weeks. Body weight of the animals was determined on days 0, 7, and 14 of the study. After 14 days, the animals were sacrificed with carbon dioxide and examined macroscopically for recognizable organ defects. No mortality was observed during the study. No adverse effects to body weight or clinical signs were noted. The acute oral LD50 for male and female rats was > 2000 mg/kg bw.

Acute Dermal Toxicity

The key study examined the acute dermal toxicity of Benzene, mono-C10-13-alkyl derivs., distn. residues (HAB). Groups of five male and five female rats were exposed dermally to concentrations of 0 and a limit dose of either 3600 (males) or 4300 mg/kg bw (females). Animals were observed for the next 14 days for mortality and clinical signs and also weighed every 7 days. At the end of the study, animals were necropsied. No mortality was observed during the study, and no adverse clinical signs were noted. Body weight gains of treated animals were also comparable to controls. Doses up to 4300 mg/kg did not cause death or produce clinical, behavioral, or anatomical alterations in female rats. Doses up to 3600 mg/kg bw did not produce adverse effects in male rats. Therefore, the acute dermal LD50 for female rats was > 4300 mg/kg bw, and male rats was > 3600 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Nov. 2, 1992-Nov. 19, 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study.
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. certificate)
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Fa. Winkelmann
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 143-167 g males, 129-135 g females
- Fasting period before study: 16 hrs
- Housing: up to 5 animals of the same sex in Makrolon Type III cages, identified by skin and tail markings and cage cards
- Diet (e.g. ad libitum): Ssniff R 10, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark


IN-LIFE DATES: From: Nov. 3, 1992 To: Nov. 19, 1992
Route of administration:
oral: gavage
Details on oral exposure:
A volume of 2.33 cm2/kg was applied via intubation to the animals.
Doses:
A preliminary dose of 2,000 mg/kg was given orally to 2 male and 2 female rats. For the limit test, 3 male and 3 female rats were given 2,000 mg/kg.
No. of animals per sex per dose:
Five of each sex were tested.
Details on study design:
The animals were examined for clinical symptoms 0.5, 1, 2, 3, 4, 5, and 6 hours after application, as well as once a day for two weeks. Body weight of the animals was determined on day 0, day 7, and day 14. After 14 days, the animals were sacrificed with carbon dioxide and examined macroscopically for recognizable organ defects.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality was observed during the study.
Clinical signs:
No adverse symptoms were observed after 14 days of observation.
Body weight:
Body weights were normal.
Gross pathology:

There were no macroscopic abnormalities in the organs.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 for both male and female rats was > 2000 mg/kg bw.
Executive summary:

This study examined the acute oral toxicity of the test substance to rats. A group of 5 male and 5 female rats were given a dose of 2000 mg/kg bw test substance. The rats were then monitored over the next 14 days for clinical signs and mortality. Body weights were taken on days 0, 7, and 14 of the study. At the termination of the study, all animals were sacrificed, and examined for macroscopic abnormalities. No animals died during the study. No adverse effects to body weight or clinical signs were noted. The acute oral LD50 for male and female rats was > 2000 mg/kg bw. The test substance is not classified as toxic under EU GHS guidelines.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
Key study is acute oral toxicity study, reliable without restriction.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study.
Qualifier:
according to
Guideline:
other: Sema. 1988. Manual of tests for assessing chemical agents toxicity, 1 ed. Brasilia: MHU.
GLP compliance:
no
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 241-267 g males, 180-208 g females
- Housing: conventional breeding station
- Diet (e.g. ad libitum): available
- Water (e.g. ad libitum): available


ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark
Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 35-53 cm2 males; 33-42 cm2 females
- % coverage: less than 10% of body surface
- Type of wrap if used: Elizabethan collars were placed on animals to prevent ingestion of test substance.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hrs


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 ml
- Constant volume or concentration used: yes
Duration of exposure:
24 hrs
Doses:
0, 3600 (males), or 4300 mg/kg (females)
No. of animals per sex per dose:
Five of each sex per dose were tested.
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were made daily, body weights were taken every 7 days
- Necropsy of survivors performed: yes
Sex:
female
Dose descriptor:
LD50
Effect level:
> 4 300 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
> 3 600 mg/kg bw
Mortality:
No animals died during the study.
Clinical signs:
No adverse clinical signs were seen during the study.
Body weight:
Body weight gain was comparable between treatment and control groups.
Gross pathology:
No abnormal pathological finding were noted.
Other findings:
Doses up to 4300 mg/kg did not cause death or produce clinical, behavioral, or anatomical alterations in female rats. Doses up to 3600 mg/kg bw did not produce adverse effects in male rats.

Average Body Weight Gain (g)

Control

3600 mg/kg bw (males)

4300 mg/kg bw (females)

Males

17.2

33.0

Females

12.4

13.4

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The dermal LD50 in female rats was > 4300 mg/kg bw, and in male rats was > 3600 mg/kg bw.
Executive summary:

This study examined the acute dermal toxicity of heavy alkylates. Groups of 5 male and 5 female rats were exposed to concentrations of 0, 3600 (males), and 4300 mg/kg bw (females) dermally. Animals were observed for the next 14 days for mortality and clinical signs. Animals were weighed every 7 days. At the end of the study, animals were necropsied. No animals died during the study, and no adverse clinical signed were noted. Body weight gains of treated animals were also comparable to controls. The acute dermal LD50 for both female rats was > 4300 mg/kg bw, and male rats was > 3600 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
3 600 mg/kg bw
Quality of whole database:
Key study is acute dermal toxicity study, reliable with restrictions.

Additional information

Justification for classification or non-classification

HAB is not expected to be acutely toxic, based on the absence of mortality or clinical signs in oral and dermal exposure studies with very high limit doses. Inhalation is not considered to be a relevant route of exposure.