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EC number: 905-287-4 | CAS number: 1638758-52-7
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Justification for type of information:
- No data are available for the target substance. Acute oral LD50 values of 121mg/kg bw, 242 mg/kg bw and 207 mg/kg bw are reported for o-, m- and p-cresols, respectively. Acute oral LD50 values of ~980 mg/kg bw are reported for xylenol and ethylphenol. Data therefore demonstrate greater toxicity for the cresols compared to mixed xylenol isomers and mixed ethylphenol isomers, with some evidence that o-cresol is the more toxic of the cresol isomers. Based on the closest structural similarity, read-across using the xylenol study is required for this endpoint. No dermal toxicity data are available for any Category substance; a waiver is appropriate for the target substance for this endpoint based on the proposed classification of the target substance as corrosive. Robust inhalation toxicity data are available for any Category substance; a waiver is appropriate for the target substance for this endpoint based on the proposed classification of the target substance as corrosive. Experimental data for o-, m- and pcresols, 2,4-xylenol and 2,6-xylenol show that classification for skin corrosivity is appropriate. Data for 3,5-xylenol do not indicate that classification for skin irritation or corrosivity are required. Classification for skin corrosivity is therefore proposed for the target substance based on the weight of evidence and following a worst case approach. Experimental data for o-, m- and p-cresols and 3,5-xylenol show severe eye irritation. Classification for severe eye damage is therefore proposed for the target substance based on the weight of evidence. Skin sensitisation studies report negative results for p-cresol and 3,5-xylenol and a positive result for 2,4-xylenol. Classification for skin sensitisation is therefore proposed for the target substance based on the weight of evidence and following a worst-case approach.
Data source
Materials and methods
- Principles of method if other than guideline:
- Method: other: 5 rabbits/dose, exposure period not given, observation up to 14 days, gross autopsy
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Reaction mass of 2,4-xylenol and 2,5-xylenol
- EC Number:
- 905-287-4
- Cas Number:
- 1638758-52-7
- Molecular formula:
- (CH3)2C6H3OH
- IUPAC Name:
- Reaction mass of 2,4-xylenol and 2,5-xylenol
- Test material form:
- solid: bulk
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- no further data
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- other: undiluted
- Details on dermal exposure:
- no further data
- Duration of exposure:
- no data
- Doses:
- 681, 1000, 1470, 2150 mg/kg bw
- No. of animals per sex per dose:
- 5 rabbits/dose
- Control animals:
- not specified
- Details on study design:
- no further data
- Statistics:
- yes, but method not mentioned
Results and discussion
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 1 380 mg/kg bw
- 95% CL:
- >= 841 - <= 2 260
- Mortality:
- 681 mg/kg bw: 1/51000 mg/kg bw: 2/51470 mg/kg bw: 2/5 2150 mg/kg bw: 4/5
- Clinical signs:
- Hypoactivity salivation, tremors ; dermal irritation: severe erythema
- Body weight:
- initial bw 2.44 - 2.61 kg; terminal bw not given
- Gross pathology:
- gross autopsy: survivors: no significant findings; decedents: hyperemia of the liver and lungs
- Other findings:
- no further details
Any other information on results incl. tables
RS-Freetext:
Signs of intoxication:
hypoactivity, salivation, tremor, severe erythema
681 mg/kg bw: 1/5 rabbit died between day 8 and day 14, but showed no signs of intoxication
1000 mg/kg bw: clinical signs developed between 4-12 hours and 2/5 rabbits diedwithin the first 2 days
1470 mg/kg bw: clinical clinical signs developed between 4-12 hours, 1/5 rabbit died on day 2 and 1/5 between day 8 and day 14
2150 mg/kg bw: clinical signs developed between 0-4 hours, death of 4/5 rabbits occurred within 4 days.
Gross autopsy revealed in survivors no significant findings; decedents showed hyperemia of the liver and lungs
Applicant's summary and conclusion
- Conclusions:
- Dermal application of the testsubstance to the skin of rabbits resulted in an LD50 value of 1380 mg/kg bw
- Executive summary:
Dermal application of the testsubstance to the skin of rabbits resulted in an LD50 value of 1380 mg/kg bw (Industrial Biotest Laboratories 1969)
The above results are suitable to be used for read across for Reaction mass of 2,4-xylenol and 2,5-xylenol, due to the category being based on structural similarity and comparable physicochemical properties, leading to similar (eco)toxicological properties.
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