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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:
From 7 JUNE 1977 to 12 AUGUST 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was conducted prior to GLP and OECD guidelines but was conducted according to acceptable procedures at the time.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Shorter observation time than recommended in OECD guideline 401: 7 days vs. 14 days
GLP compliance:
not specified
Remarks:
This study was prior to GLP and OECD guidelines but was conducted according to acceptable procedures at the time.
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Galaxolide 50
- Date received: 7/15/77
- Physical state: A clear liquid
- Lot/batch No.: SG-087-2030
- Purity: Assumed 50% active

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 104-141 grams
- Fasting period before study: YES, overnight

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
0.215, 0.464, 1.0, 2.15 and 4.64 g/kg bw Galaxolide 50, equivalent to doses of HHCB of 0.14, 0.30, 0.65, 1.4 and 3.0 g/kg when corrected for the 65% dilution).
No. of animals per sex per dose:
5 females per dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Immediately after dosing at one, four and 24 hrs and once daily thereafter for a total of 7 days.
- Necropsy of survivors performed: yes
Statistics:
Mortality data was analyzed statistically, utilizing the tables of Horn, HJ. Biometrics 12, 311, 1956.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 4 640 mg/kg bw
Remarks on result:
other: The LD50 was >3 g/kg BW expressed in HHCB equivalents.
Mortality:
There was one death as a result of gavage error at 1.0 g/kg but no deaths at any other dose
Clinical signs:
One animal at 2.15 g/kg appeared distressed shortly after dosing but appeared normal after 2h. There were no effects at the high dose.

Any other information on results incl. tables

Table 1: mortaility in the study.

Time of death Time of death
Dose (g/kg) Concentration (%) Immediate Hours (1-24) Days (2-7)
0.215 100 0/5 0/5 0/5
0.464 100 0/5 0/5 0/5
1 100 0/5 1/5 1/5
2.15 100 0/5 0/5 0/5
4.64 100 0/5 0/5 0/5

LD50= >4.64 g/kg total product

Since 50% active LD50= >2.15 g/kg

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The material does not need to be classified for acute oral toxicity.
Executive summary:

Galaxolide 50 (Non-GLP; 65% HHCB in diethyl phthalate (DEP)) was administered undiluted (hence, there was variation in volume of dosing) by oral intubation at doses of 0.215, 0.464, 1.0, 2.15 or 4.64 g/kg bw (equivalent to doses of HHCB of 0.14, 0.30, 0.65, 1.4, 3.0 g/kg when corrected for the 65% dilution) to groups of 5 female Charles River Sprague Dawley rats (initial bodyweight 104–141 grams) that were then observed for mortality and signs of effects for 7 days. There was one death as a result of gavage error at 1.0 g/kg but no deaths at any other dose. One animal at 2.15 g/kg appeared distressed shortly after dosing but appeared normal after 2 hr. There were no effects at the high dose. An LD50of >4.64 g/kg bw (equivalent to >3 g/kg bw HHCB) was calculated. This study was conducted prior to GLP and OECD guidelines but was conducted according to acceptable procedures at the time.