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Diss Factsheets

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:
key study
Study period:
1983-09-27 - 1983-12-2
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline conforming study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
of 1981
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
3-hydroxy-2-naphthoic acid
EC Number:
202-180-8
EC Name:
3-hydroxy-2-naphthoic acid
Cas Number:
92-70-6
IUPAC Name:
3-hydroxy-2-naphthoic acid
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): BONS TTR
- Substance type: light yellowish powder
- Physical state: solid
- Analytical purity:
- Impurities (identity and concentrations): about 1% ß-Naphthol
- Lot/batch No.: 1297/83
- Storage condition of test material: at about 22°C in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG breeding colony
- Weight at study initiation: male 197 g (mean); female 191 g (mean)
- Fasting period before study: 16h
- Housing: makrolon cage, groups of 5
- Diet (e.g. ad libitum): rat diet Altromin 1324, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
2% aqueous carboxymethyl cellulose (CMC)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25%
- Amount of vehicle (if gavage): 1.25ml/kg bw in the lowest dose group and 5.0 ml/kg bw in the highest dose group

Doses:
male: 800, 1000, 1250 mg/kg bw
female: 315, 500, 800, 1000, 1250 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
weighth was determined: 0, 7, 14 days post application,
clinical signes were observed: 10, 30, 60 min; 2, 4, 6 h, 1, 2, 3, 4-14 d post application

- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
Probit analysis

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
823 mg/kg bw
95% CL:
>= 581 - <= 1 070
Sex:
male
Dose descriptor:
LD50
Effect level:
869 mg/kg bw
95% CL:
>= 394 - <= 1 350
Sex:
female
Dose descriptor:
LD50
Effect level:
795 mg/kg bw
95% CL:
>= 485 - <= 1 320
Mortality:
315 mg/kg bw : 0/5 (f)
500 mg/kg bw: 2/5 (f)
800 mg/kg bw: 1/5 (m), 2/5 (f)
1000 mg/kg bw: 3/5 (m), 3/5 (f)
1250 mg/kg bw: 5/5 (m), 4/5 (f)
all deaths occured 35 - 200 min. post application
Clinical signs:
other: Similar clinical signs were observed in both sexes. Clinical signes included reduced activity, accelerated breathing, closure of eyes and diarrhea (occurring 30-60 min post application).
Gross pathology:
Surviving animals were free of pathological changes at the end of the observation period (14 d). Gastrointestinal irritation and dark or mottled livers were observed in the dead animals.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information REGULATION (EC) No 1272/2008 Criteria used for interpretation of results: EU
Conclusions:
LD50 male/female: 823 mg/kg bw
LD50 male: 869 mg/kg bw
LD50 female: 795 mg/kg bw
Executive summary:

3-Hydroxy-2-naphthoic acid was tested for its acute toxicity in the rat according to OECD Guideline 401 and in compliance with GLP. An oral LD50 of 823 mg/kg bw was determined for both sexes, 869 mg/kg for males and 795 mg/kg for females. Mortality occurred within 35 -200 minutes after dosing. Principal clinical signs were reduced spontaneous activity, ventral and lateral recumbency and crawling in all dose groups, in addition to closure of eyes, hunched posture and accelarated breathing in several dose groups starting at approximately 10 to 30 min post administration. In addition, diarrhea was noted in several dose groups starting mainly at approximately 30 to 60 min post administration. As from the day after the administration all surviving animals were free from clinical signs. Bodyweight was unaffected by treatment with the test substance. No macroscopic pathology findings were evident in animals which survived the 14-day post-dosing observation period, whilst dark or mottled livers and signs of gastrointestinal irritation were evident in decedent animals. There was no indication of relevant sex-related differences in toxicity of the substance after single oral administration.