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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:
1984-05-23 to 1984-06-20
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
p-(1,1,3,3-Tetramethylbutyl)-phenol
IUPAC Name:
p-(1,1,3,3-Tetramethylbutyl)-phenol
Constituent 2
Chemical structure
Reference substance name:
4-(1,1,3,3-tetramethylbutyl)phenol
EC Number:
205-426-2
EC Name:
4-(1,1,3,3-tetramethylbutyl)phenol
Cas Number:
140-66-9
Molecular formula:
C14H22O
IUPAC Name:
4-(2,4,4-trimethylpentan-2-yl)phenol
Details on test material:
- Name of test material (as cited in study report): Octylphenol PT
- Physical state: solid
- Analytical purity: 96% (provided by sponsor, not part of the study report)
- Impurities (identity and concentrations): not mentioned
- Composition of test material, percentage of components: not mentioned
- Purity test date: not mentioned
- Lot/batch No.: not mentioned
- Production date of the lot/batch: not mentioned
- Stability under test conditions: not mentioned
- Storage condition of test material: not mentioned

Test animals

Species:
rat
Strain:
other: Wistar: Bor strain, WISW (SPF TNO)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: average weight male = 201 g; female = 150 g
- Fasting period before study: 16 hours
- Housing: 1 - 5 animals in Makrolon cages, type III
- Diet (e.g. ad libitum): R10 Complete feed for rats ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: 4 - 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
paraffin oil
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED:
10 - 20 ml/kg bw
Doses:
3160, 3980, 4495 and 5010 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Examination of clinical signs up to 6 hours after the treatment and daily observations thereafter; bodyweights were determined before treatment, and 1, 7 and 14 days after treatment.
- Necropsy of survivors performed: yes
- Other examinations performed: no
Statistics:
The means of the body weights were calculated.
The LD50 was determined according to Litchfield and Wilcoxon and reported with 95% confidence limits (J. Pharmacol. Exp. Ther. 96, 1949, 99)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
4 040 mg/kg bw
95% CL:
3 640 - 4 484
Mortality:
3160 mg/kg bw: one male and one female died after 48 h
3980 mg/kg bw: two males and one female died after 28-170 h
4495 mg/kg bw. two males and five females died after 48 h
5010 mg/kg bw. all animals died after 48 h
Clinical signs:
other: The signs observed 30 minutes after administration were ruffled fur, crouched posture, slight sedation and ataxia, diarrhoea, diuresis, prone position, hypothermia, cyanosis, labored breathing, staggering, trembling and small deep-red eyes. One animal got
Gross pathology:
Post mortem dissection revealed hyperaemia of the gastro-intestinal tract, as well as of peritoneum and pleura and sporadic spots on kidneys, liver and lung. One animal indicated a redness mucosa of the bladder.
Dissection of surviving animals at the end of the experiment showed partially hyperaemia of the small intestine,
swelling of the gastric mucosa and fusion of liver, stomach and spleen with peritonium.

Any other information on results incl. tables

Table #: Number of animals dead [and with evident toxicity] [and time range within which mortality occurred]

 

Dose
(mg/kg bw)

Mortality (# dead/total)

Time range of deaths (hours)

Number with evident toxicity (#/total)

Male

Female

Combined

Male

Female

Combined

3160

1 / 5

1 / 5

2 / 10

48 

5 / 5

5 / 5

10 / 10

3980

2 / 5

1 / 5

3 / 10

28 - 170

5 / 5

5 / 5

10 / 10

4495

2 / 5

5 / 5

7 / 10

48

5 / 5

5 / 5

10 / 10

5010 5 / 5 5 / 5 10 / 10 48 5 / 5  5 / 5 10 / 10

 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on an LD50 (rat) of 4040 (3640-4484) mg/kg bw p-(1,1,3,3,-Tetramethylbutyl)-phenol is not classified as acute toxic
Executive summary:

In an acute oral toxicity study, groups of fasted Wistar rats (5/sex) were given a single oral dose p-(1,1,3,3,-Tetramethylbutyl)-phenol in paraffin oil at doses of 3160, 3980, 4495 and 5010 mg/kg bw and observed for 14 days. 

Oral LD50    Combined = 4040 mg/kg  bw (3640 - 4484)

(1,1,3,3,-Tetramethylbutyl)-phenol is of LOW Toxicity based on the combined LD50.                 

The signs observed 30 minutes after administration were ruffled fur, crouched posture, slight sedation and ataxia, diarrhoea, diuresis, prone position, hypothermia, cyanosis, labored breathing, staggering, trembling and small deep-red eyes. One animal got anorexia. The treated animals showed signs of toxicity for up to 7 days.