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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Data from Handbook or collection of data. Restrictions: number of animals per dose, number of dose levels, and dose levels are not reported. Read-across justification: The substance is hydrolytically unstable. When it comes in contact with water or moisture complete hydrolysis will take place with no significant reaction products other than alcohol and hydrated titanium dioxide. This rapid hydrolysis (hydrolysis half-life < 3 minutes to < 2 hours) is the driving force for the toxicokinetics of target substance. Because of the rapid hydrolysis, the influence of the mode of administration through inhalation, dermal and oral is related to the hazardous degradation product (alcohol) released from the target substance. The identification of degradation products from the hydrolysis study conducted for the target substance verifies that there are no impurities in the alcohol released from the target substance, which might change the hazardous properties of the target substance compared to the properties of the pure alcohol. As there is a mechanistic reasoning to the read-across, the unnecessary animal testing is avoided by using the read-across data from the degradation product (relevant alcohol) to evaluate irritation, sensitization and the short term and long-term toxicological effects and mutagenicity of the target substance.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
dose levels, number of animals per dose level not reported
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Analytical purity: technical grade

Test animals

Species:
rat
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: own breeding facility
- Age at study initiation:
- Weight at study initiation: 150 - 180 g
- Fasting period before study: 18 hrs
- Housing:
- Diet (e.g. ad libitum): standard diet pellets type K; Staatliche Zentralstelle für Versuchstierzucht unnd -versorgung, Berlin -Lichtenberg, GDR
- Water (e.g. ad libitum): tap water
- Acclimation period: n.a.


ENVIRONMENTAL CONDITIONS
no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
Dose levels not reported. Doses were geometrically spaced.
No. of animals per sex per dose:
not reported
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were daily observed and weekly weighed.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: no.
Statistics:
LD50 was calculated according to Litchfield and Wilcoxon (1949) J. Pharmacol. Exp. Therap. 96: 2.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
3 290 mg/kg bw
95% CL:
2 870 - 3 790
Clinical signs:
Narcosis.

Any other information on results incl. tables

The oral LD50 was 3290 mg/kg (range p=0.05: 2870-3790 mg/kg). Deaths occurred
within 2 days after dosing. Animals died in narcosis with no other findings.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral toxicity of undiluted 2-EH was examined in a protocol that is similar to OECD test guideline 401.The LD50 value was 3290 mg/kg bw in fasted male rats.
Executive summary:

The acute oral toxicity of technical grade 2 -EH was examined in a protocol that was similar to the recently retracted OECD test guideline 401. 36 fasted male rats received the unchanged test material by oral gavage; the doses were geometrically spaced. The dose levels and the number of animals per dose level were not reported. The study is therefore regarded to be valid with restrictions.

The LD50 was 3290 mg/kg bw [range (p=0.05): 2870 – 3790 mg/kg bw] in fasted male rats receiving the undiluted 2-EH by oral gavage. Deaths occurred within 2 days, and the animals died in narcosis without any other signs of toxicity (Schmidt P, Gohlke R, and Rothe R, 1973).