Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The purity of the test substance, the vehicle, the strain and the sex of the rabbits were not reported. The protocol appeared to be similar from the standard method. The GLP were not mentioned but the study was performed before the GLP standard was established.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
No information
Author:
Kirwin C.J., Galvin J.B.
Year:
1982
Bibliographic source:
Journal Patty's Industrial Hygiene and Toxicology. 4th ed. New York: John Wiley Sons, 448-449, 481-485. Ethers: chapter 8.
Reference Type:
study report
Title:
Unnamed
Year:
1978
Reference Type:
publication
Title:
Monographs on fragrance raw materials
Author:
Opdyke DL, Letizia C.
Year:
1982
Bibliographic source:
Food Chem Toxicol, 20, 697-701.

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Acute dermal toxicity
GLP compliance:
no
Test type:
other: dermal toxicity
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no data

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
ADMINISTRATION / EXPOSURE: on abraded or intact skin
No more details
Duration of exposure:
no data
Doses:
2500, 3530, 5000 mg/kg bw
No. of animals per sex per dose:
4 animals per dose, sex unspecified.
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: no data
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross examination
Statistics:
Harris method

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
4 600 mg/kg bw
95% CL:
3 800 - 5 400
Remarks on result:
other: In the same study, dermal irritation was evaluated.
Mortality:
3/4 animals at 5000 mg/kg bw
Clinical signs:
at 2500 and 3530 mg/kg bw slight diarrhea was noted.
At 5000 mg/kg bw, 3/4 rabbits died on days 1 and 8 and slight diarrhea, anorexia, lethargy, pilorection, emaciation, yellowish discharge at nose,
ataxia and flaccid muscle tone were observed.
Body weight:
no data
Gross pathology:
Necropsy revealed no abnormalities in all animals treated with 3530 mg/kg bw and in 2/4 rabbits treated with 2500 mg/kg bw.
At 2500 mg/kg bw dose level, red areas in intestines were observed in 2/4 animals; dark liver in 2/4 animals; large spleen in 1/4 animals; skin
hard/thick in 1/4 animals.
At 5000 mg/kg dose level, necropsy revealed red exudate in the nose/mouth in 2/4 rabbits; brown anogenital exudate in 1/4 animals; red anogenital exudate in 1/4 animals; red areas in intestines in 2/4 animals; bloated intestines in 1/4 animals; stomach covered with blue-white dots in 1/4 animals; dark liver in 1/4 animals; mottled liver in 2/4 animals; dark lungs in 2/4 animals; dark kidney in 1/4 animals; dark spleen in 1/4 animals; skin edema
in 1/4 animals; skin redness in 1/4 animals; and blood in urine in 2/4 animals.
Other findings:
no data

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
- Interpretation of results: not classified
- Criteria used for interpretation of results: other: EU GHS

SUMMARY:
Executive summary:

In an acute dermal toxicity study (Moreno, 1978), groups of 4 rabbits (sex unspecified) were dermally exposed to guaiacol at doses of 2500, 3530 and 5000 mg/kg bw.

Dermal LD50 = 4600 mg/kg bw (95% C.I: 3800-5400 mg/kg).

Guaiacol is not classified based on the LD50 of 4600 mg/kg bw/day identified in this study and according to EU classification criteria (Annex VI of Directive 67/548/EEC and Annex I of Regulation (EC) n°1272/2008).