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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 7 JUNE 1977 to 12 AUG 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was carried out prior to GLP and OECD guidelines but was conducted according to acceptable procedure at that 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 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Animals used where lighter than described in OECD guideline 402. 108 - 187 grams vs 200 - 300 grams
GLP compliance:
not specified
Remarks:
This study was carried out prior to GLP and OECD guidelines but was conducted according to acceptable procedures at that 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
- The material as tested was a commercial sample containing 65% HHCB in diethyl phthalate (DEP). The actual LD50 value for HHCB is therefore equivalent to > 6500 mg/kg bw.
- 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:
Initial bodyweight 108-187 g

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Duration of exposure:
7 days
Doses:
0.464, 1.0, 2.15, 4.64 and 10.0 g/kg bw Galaxolide 50, equivalent to doses of HHCB of 0.30, 0.65, 1.4, 3.0 and 6.5 g/kg when corrected for the 65% dilution
No. of animals per sex per dose:
5
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:
> 10 000 mg/kg bw
Remarks on result:
other: The LD50 was > 6500 mg/kg BW expressed in HHCB equivalents.
Mortality:
There were no deaths at any dose.
Clinical signs:
All animals in the high dose group exhibited urine staining on their fur.
Gross pathology:
There were no major effects noted in any of the animals in any dosage level.

Any other information on results incl. tables

Table 1: Mortalility in the study.
  Time of death Time of death Time of death
   Dose (g/kg)   Concentrations (%)   Immediate Hours (1 -24)   Days (2 -7)
 0.464 100  0/5  0/5  0/5 
100  0/5  0/5  0/5 
2.15 100 0/5  0/5  0/5 
4.64  100  0/5  0/5  0/5 
10  100 0/5  0/5  0/5 

LD50= > 10 g/kg total product

Since 50% active, LD50 = > 5 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 dermal toxicity
Executive summary:

Galaxolide 50 (65% HHCB in DEP) was administered undiluted by inunction to the shaved skin (area not reported) of groups of five female Charles River Sprague Dawley rats (initial bodyweight 108–187 g) in doses of 0.464, 1.0, 2.15, 4.64 or 10.0 g/kg bw (equivalent to 0.30, 0.65, 1.4, 3.0, 6.5 g/kg HHCB) that were then observed for 7 days. There were no deaths at any dose but all animals in the high dose group exhibited urine staining on their fur. A dermal LD50 of >10.0 g/kg bw (equivalent to >6.5 g/kg bw HHCB) was reported (Minner and Foster, 1977). This study was conducted prior to GLP and OECD guidelines but was conducted according to acceptable procedures at the time.