Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
not specified
Test type:
other: LD50
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Hexan-1-ol
EC Number:
203-852-3
EC Name:
Hexan-1-ol
Cas Number:
111-27-3
Molecular formula:
C6H14O
IUPAC Name:
hexan-1-ol

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS

- Weight at study initiation: 2.3 to 2.9 kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
- test material was applied to intact and abraded skin.
Duration of exposure:
24 hours
Doses:
0.5, 1, 1.5 and 2 g/kg
No. of animals per sex per dose:
2M, 2F
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: The animals were observed for clinical signs of intoxication several time during the day of dosing and daily thereafter throughout  the 14 day observation period.  The animals were weighed at sacrifice.

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 1 500 - < 2 000 mg/kg bw
Mortality:
- Time of death: Within 48 hours of dosing.
- Number of deaths at each dose: 0/4, 1F/4, 1M/4, 4/4.
Clinical signs:
Prior to death generalised weakness and/or unthriftiness, diarrhoea, hypothermia, pallor, loss of corneal and palepebral reflexes, hunched position, flaccidity, slow shallow repsiration and coma. Similar signs of intoxication but less marked were observed in survivors. All survivors appeared systemically normal within 96 hours of dosing. 
Body weight:
Among survivors there was weight loss in 3 rabbits, one rabbit maintained a constant weight, while the remaining survivors showed weight gains within expected limits.
Gross pathology:
Premature decedents showed at gross necropsy, in addition to dermal irritation, severe haemorrhaging and/or bloody,  gelatinous infiltration of the subcutis, depletion of fatty tissue, slight accumulation of clear fluid within the peritoneal cavity, moderate congestion of liver and kidneys and severe haemorrhaging and/or blanching  of the gastric mucosa. Amongst survivors (10), other than residual skin damage, gross necropsy findings were unremarkable in 7 rabbits. In the remaining 3 rabbits there was a slight to moderate accumulation of clear viscous liquid in the peritoneal cavity and/or a dpeletion of visceral fat and mottling or stippling of the renal cortex.

Any other information on results incl. tables

Rabbit dermal LD50 (24 hour occlusive exposure) 1.5 - 2 g/kg. This is a combined value for intact and abraded skin and males/females. 

At 24 hours all animals showed slight to moderate erythema especially of the ventral region. Survivors all showed wrinkling 

and/or coriaceousness, hardening and desquamation of the skin which persisted throughout the observation period.



Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The rabbit dermal 24 hour occlusive LD50 (combined applications to intact and abraded skin) is 1500-2000 mg/kg.